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Not applicable clinical trials

Not applicable lung cancer studies.

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Not Yet Recruiting · Not applicable · NCT07898241

Using an Artificial Intelligence Software Tool (iSeg) During Radiation Treatment Planning for Patients With Lung Tumors

This clinical trial studies whether an artificial intelligence (AI) software tool called iSeg can be safely and effectively used during routine radiation treatment planning for patients with lung tumors. Typical radiation treatment planning involves physicians manually outlining the tumors to plan where the radiation therapy will be delivered. This process can be time consuming and may vary between physicians. iSeg uses AI to analyze computed tomography (CT) images and generate a proposed tumor outline that can then be reviewed and modified by the treating physician during radiation treatment planning which may help improve accuracy and provide more consistent results and better planning. iSeg may be safe and effective to use during radiation treatment planning for patients with lung tumors.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVRadiation therapyTreatmentInterventional
Active Not Recruiting · Not applicable · NCT02630615

Circulating Tumor Cells (CTC) in Lung Cancer

The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

Observational
Recruiting · Not applicable · NCT07176000

Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington State, SACRED LUNGS Trial

This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state. Lung cancer is the leading cause of cancer death in the United States among American Indian (AI) and Alaska Native (AN) people, and the incidence of lung cancer is higher in this population in the Northern and Southern Plains, Alaska, and Pacific Coast regions. In Washington state, AI/AN people also have twice the rate of commercial cigarette smoking than the overall population. LCS with annual low-dose chest computed tomography (CT) can reduce lung cancer death and is recommended in people 50-80 years of age with current or recent (within 15 years) tobacco use and a 20 pack-year or greater smoking history. Despite this, AI and AN people are less likely to receive LCS which may be due to barriers they face making it difficult to receive LCS. PN services are designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN services in this trial have been tailored for the tribal communities in western Washington state. The services are designed to help participants overcome the unique barriers that their tribal communities face and improve the uptake of LCS.

Supportive or behavioral careScreeningInterventionalSurvivorship and quality of life
Not Yet Recruiting · Not applicable · NCT07005297

Clinical Genetics Branch Eligibility Screening Survey

Background: Clinical Genetics Branch (CGB) researchers study individuals and populations at high genetic risk of cancer in order to improve our understanding of cancer and to improve cancer care. There are currently 6 open clinical genetics studies at the CGB eligible for this screening process. * 02C0052: Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndromes: A Natural History Study (Cancer in Bone Marrow Failure) * 11C0255: Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome (Li Fraumeni Syndrome Study) * 11C0034: DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study (Pleuropulmonary Blastoma) * 02C0211: Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma (Melanoma-Prone Families) * 10CN188: Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-susceptibility Genes (Sporadic Chordoma Study) The following studies have their own study-specific screeners. If you are interested in these studies, please click the links below to fill out the relevant study screener: * 001109: Defining the Natural History of Squamous Cell Carcinoma in Fanconi anemia (SCC Screening in FA): https://service.cancer.gov/fanconi * 20C0107: Clinical, Genetic, and Epidemiologic Study of Children and Adults with RASopathies (RASopathies Study): https://service.cancer.gov/myras Objective: To find people to participate in active CGB cancer research studies. Eligibility: People of any age who meet the eligibility criteria for one of the open CGB cancer research studies. You can learn more about the CGB cancer research studies by clicking on the links to the study-specific websites above. This typically involves a personal or family history of certain cancers that are being studied by researchers at CGB. Design: Participants will fill out a screening questionnaire to determine if they are eligible to participate in one or more CGB clinical genetics studies. The survey asks about personal health history, including cancer; family history; and genetic testing results and takes 15 to 20 minutes. Each study has its own eligibility criteria. Survey respondents will select which study (or studies) that are interested in participating in, and the relevant study team(s) will review the screener to determine eligibility to participate in the study. Participants who are determined to be eligible for a study based on their screener will be contacted by the respective study team to learn more about the study and to consent to enroll in the study if they choose to do so. Participants who consent to enroll in a study may be asked to provide medical records; samples such as blood, saliva, or other tissues; and to participate in activities such as phone interviews or surveys. They may be invited for evaluations at the clinical center. Every study activity is voluntary. None of the studies provide treatments. Participants may be contacted to consider enrolling in future studies.

Observational
Active Not Recruiting · Not applicable · NCT07176559

Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care

The purpose of this study is to address the need for effective spiritual care support for patients with lung and gastrointestinal cancer. This study will examine how spiritual care affects spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication.

Metastatic or stage IVSupportive or behavioral careSupportive CareInterventional
Completed · Not applicable · NCT05930418

Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction. Primary Objectives: (Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer. CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness. (Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer

DiagnosticInterventional
Recruiting · Not applicable · NCT00001532

Role of Genetic Factors in the Development of Lung Disease

This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers. Optional CT Sub-study The standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques. Specifically, the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease status. This optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF. Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison. One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan.

Observational
Recruiting · Not applicable · NCT01143480

Study of the Effect of Innate on the Inflammatory Response to Endotoxin

Background: \- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers. Objectives: \- To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * The study will involve one visit of 45 to 60 minutes. * Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking. * Participants will provide a blood sample for research purposes.

Observational
Recruiting · Not applicable · NCT06026111

Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial

The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors. The names of the study interventions involved in this study are: * High-intensity interval training (HIIT) * Moderate-intensity continuous training (MICT) * Usual care (UC)

ImmunotherapySupportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT00033137

Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer

This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck. People with BHD are at increased risk of developing kidney cancer. Scientists have identified the chromosome (strand of genetic material in the cell nucleus) that contains the BHD gene and the region of the gene on the chromosome. This study will try to learn more about: * The characteristics and type of kidney tumors associated with BHD * The risk of kidney cancer in people with BHD * Whether more than one gene causes BHD * The genetic mutations (changes) responsible for BHD Individuals with known or suspected Birt Hogg-Dube syndrome, and their family members, may be eligible for this study. Candidates will be screened with a family history and review of medical records, including pathology reports for tumors, and films of computed tomography (CT) and magnetic resonance imaging (MRI) scans. Participants may undergo various tests and procedures, including the following: * Physical examination * Review of personal and family history with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor * Chest and other x-rays * Ultrasound (imaging study using sound waves) * MRI (imaging study using radiowaves and a magnetic field) * CT scans of the chest and abdomen (imaging studies using radiation) * Blood tests for blood chemistries and genetic testing * Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample for microscopic evaluation) * Cheek swab or mouthwash to collect cells for genetic analysis * Lung function studies * Medical photography of skin lesions These tests will be done on an outpatient basis in either one day or over 3 to 4 days. When the studies are complete, participants will receive counseling about the findings and recommendations. Individuals with kidney lesions may be asked to return periodically, such as every 3 to 36 months, based on their individual condition, to document the rate of progression of the lesions.

SurgeryObservational
Active Not Recruiting · Not applicable · NCT04819997

A Nurse-Led Intervention for Fear of Progression in Advanced Cancer

This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.

Locally advancedMetastatic or stage IVSupportive CareInterventional
Recruiting · Not applicable · NCT00001823

Evaluation for NCI Surgery Branch Clinical Research Protocols

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols. Eligibility: Patients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol. Design Patients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol.

SurgeryObservational
Active Not Recruiting · Not applicable · NCT04387656

NCI COVID-19 in Cancer Patients, NCCAPS Study

This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

Metastatic or stage IVObservational
Recruiting · Not applicable · NCT06869447

New York Better Breathing Study

This clinical trial evaluates the effects of whether breathing exercises at home can reduce symptoms and help stage I-III lung cancer survivors stay active. Over 70% of lung cancer survivors have trouble breathing, feel tired, and have lower levels of fitness. This is often because their breathing muscles are weaker after surgery. Many survivors find it hard to exercise, which affects their quality of life and overall survival. A training program to strengthen these muscles might reduce breathing problems, lower fatigue, and improve quality of life. Staying active could also help boost the immune system to fight cancer. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Participating in a home-based RMT intervention may reduce symptoms from cancer or treatment in lung cancer survivors.

Early-stage or resectableLocally advancedSurgerySupportive or behavioral careSupportive Care
Recruiting · Not applicable · NCT04981119

Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing

Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.

Non-small cell lung cancer (NSCLC)MesotheliomaCell or gene therapyObservational
Recruiting · Not applicable · NCT02682667

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

Background: Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments. Objective: To better understand the biology of malignancies and why certain cancers respond differently to treatment. Eligibility: Adults at least 18 years old with cancer or a pre-cancerous condition. Design: Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology. Participants will send tissue blocks or slides from their original tumor biopsy. At least once, participants will have a medical history, physical exam, and blood and urine tests. Participants may have the following tests. They may have them more than once: Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm. Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle. Piece of cancer tissue taken by a needle and syringe. Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures. A small piece of skin removed. Participants will be contacted by phone once a year to find out how they are doing.

Non-small cell lung cancer (NSCLC)ImmunotherapyObservational
Active Not Recruiting · Not applicable · NCT02194738

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Non-small cell lung cancer (NSCLC)Early-stage or resectableImmunotherapyTargeted therapyChemotherapy
Withdrawn · Not applicable · NCT06552000

Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.

Non-small cell lung cancer (NSCLC)Early-stage or resectableSurgeryTreatmentInterventional
Not Yet Recruiting · Not applicable · NCT07282444

A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial

This clinical trial tests a new way to share radiation therapy plans using the Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) workflow to improve communication and collaboration between radiation oncologists (ROs) and radiologists when determining cancer targets for radiation treatment. Systemic barriers limit critical communication between radiation oncologists and radiologists and can lead to both under and overdosing of radiation therapy (RT) tumor targets and failures to properly interpret post-treatment imaging. The limited formal diagnostic radiology training of many providers can make differentiating normal from disease imaging findings during target determination difficult, especially in complex disease sites like the lung, head, and neck. Inaccurate target determination may result in cancer return, excess toxicity, or both. Likewise, radiologists who cannot access prior RT plans may mistake expected RT changes for recurrent cancer or overlook true progression. The CORRECT workflow was developed by ROs and radiologists to address RO-radiology communication barriers by facilitating sharing of comprehensive RT target contours during RT planning. The CORRECT workflow begins with the normal process of RO target contouring. Computed tomography (CT) images are then fused with RT targets and pushed to a pre-designated Picture Archiving and Communications System (PACS) software folder accessible by the radiology department. The radiologist can then review the fused images at their chosen time and annotate images to indicate potential deviations (e.g., not avoiding normal tissue or not including all tumor). The RO reviews the annotated images and decides if any changes to treatment targets are needed for the final treatment plan. Through this independent, asynchronous review of high-quality images, CORRECT overcomes many of the limitations of existing communication methods between RO-radiologist, fostering a more collaborative, efficient, and precise approach to cancer treatment planning.

Recurrent or relapsedRadiation therapySupportive or behavioral careHealth Services ResearchInterventional
Recruiting · Not applicable · NCT05292521

Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer

This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing standard of care surgery or stereotactic body radiation therapy (SBRT). Providing quality of life outcome data to patients deciding between surgery and SBRT may help decrease decision regret and increase patient satisfaction with their care.

Non-small cell lung cancer (NSCLC)Early-stage or resectableRadiation therapySurgeryHealth Services Research
Recruiting · Not applicable · NCT02984761

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

Non-small cell lung cancer (NSCLC)Early-stage or resectableRadiation therapySurgeryTreatment
Recruiting · Not applicable · NCT07871656

Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)

The goal of this observational study is to learn whether a urine-based test that measures volatile organic compounds (VOCs) can help detect lung cancer in people who have never smoked. The study will include adults who have never smoked, both with and without lung cancer. The main questions it aims to answer are: Can a urine VOC biosensor distinguish between people who have lung cancer and those who do not? Could this urine-based biomarker serve as a non-invasive approach for the early detection of lung cancer in people who are not currently eligible for standard lung cancer screening? Researchers will compare participants with lung cancer to participants without lung cancer to determine whether the urine VOC signature can identify differences between the two groups. Participants will: Provide a urine sample for VOC testing. Provide health and demographic information as required by the study. Be classified into groups based on whether they have been diagnosed with lung cancer.

Observational
Terminated · Not applicable · NCT06654245

Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors

This clinical trial evaluates whether a shared response plan (SHAREDCare) improves follow-up care for lung cancer survivors. As the number of cancer survivors increases, there is a new need for high-quality chronic illness care. High-quality chronic illness care can be difficult to deliver and involves working with the patient to be certain they have what they need to be actively involved with their care to meet their needs. SHAREDCare allows the patient to work with a navigator to review identified distress and social needs. The patient and navigator discuss the needs and develop a shared response plan to address the needs in ways that consider the patient's current behaviors, beliefs, and motivation. The plan also establishes specific patient goals, anticipates barriers, and establishes how the navigator will follow-up on the needs and adjust care and assistance when needed. Using a shared response plan may improve follow-up care for lung cancer survivors.

Early-stage or resectableLocally advancedMetastatic or stage IVSupportive or behavioral careSupportive Care
Active Not Recruiting · Not applicable · NCT05215769

A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer

This clinical trial tests whether a video intervention improves patient understanding of tumor genomic testing in patients with cancer that has spread to other parts of the body (metastatic). Measuring how the video intervention affects patient understanding of tumor genomic testing in patients with metastatic cancer may help doctors provide patient-centered care by effectively communicating the importance of tumor genomic testing.

Metastatic or stage IVSupportive or behavioral careHealth Services ResearchInterventional
Not Yet Recruiting · Not applicable · NCT06963970

Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans

The investigators aim to support care partner's well-being and satisfaction with VA care and decrease their work burden by offering extra support from a trained Community Health Worker who will help connect the care partner to helpful resources in their communities and in the VA. The investigators also hope to help Veterans well-being and satisfaction with VA care by supporting their care partner more sufficiently allowing the care partner to focus on caregiving tasks.

Supportive CareInterventional
Recruiting · Not applicable · NCT05620329

UNC Pleural Fluid Registry

Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.

Observational
Completed · Not applicable · NCT05832008

Increasing Adherence to Lung Cancer Screening

Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.

Supportive or behavioral careHealth Services ResearchInterventional
Enrolling By Invitation · Not applicable · NCT04450927

Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors

Background: Researchers seek ways to study people s medical problems in order to teach and further general knowledge. The ability to assess and treat people with a wide range of diseases is critical to training people to be good doctors. It is also needed to keep medical staff up to date. In this study, researchers want to study the course of some illnesses to learn more about them. To do this, they will collect and review people s medical records. In some cases, they may also provide treatment. Objective: To collect data that may be used to help researchers create ideas for future research. Eligibility: People age 2 and older who have or are suspected to have a medical condition for which they have been referred to NIH s National Heart, Lung, and Blood Institute, as well as stem cell donors Design: Participants may be screened with a review of the following: Medical records Scans and images Other existing samples and reports. Participants medical data will be collected from the standard care they receive. This includes their routine blood and urine tests, X-rays and scans, and other tests to diagnose or follow their medical condition. Data will also be collected from the treatments they may receive. For stem cell donors, data from apheresis procedures will be collected. Demographic data will also be collected. All of the data will be kept in the medical records or on secure network drives. Some participants may need to be treated for their medical condition. If so, they will sign a separate consent form for that treatment. Participation lasts up to 2 years.

Observational
Recruiting · Not applicable · NCT07535008

Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease

This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.

PreventionInterventional
Recruiting · Not applicable · NCT07646847

A Study of a Side Effects and Resource Navigation Program for People With Cancer

The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.

ImmunotherapyDiagnosticInterventionalSurvivorship and quality of life
Active Not Recruiting · Not applicable · NCT04056247

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.

Non-small cell lung cancer (NSCLC)Small cell lung cancer (SCLC)Early-stage or resectableLocally advancedMetastatic or stage IV
Recruiting · Not applicable · NCT06791057

Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Dyspnea, or breathlessness, is one of the most common and distressing symptoms experienced by patients with advanced lung cancer. The purpose of this multi-site trial is to test the effectiveness of a dyspnea intervention (called BREEZE+) that includes three brief nurse-delivered sessions and access to a digital health app that teaches and reinforces patients' use of skills for managing and coping with this highly debilitating symptom. This study will lay the groundwork for a follow-up pragmatic implementation trial integrating BREEZE+ into usual oncology care for patients with advanced lung cancer experiencing dyspnea.

Supportive or behavioral careSupportive CareInterventional
Enrolling By Invitation · Not applicable · NCT00001620

Screening for Hematology Branch Protocols

This study allows the evaluation of subjects in order to determine their ability to safely participate in other active research studies. After subjects complete the screening process, they will be offered the opportunity to participate in an active research study, or if no appropriate studies are available information and recommendations will be provided for other treatment options.

Observational
Active Not Recruiting · Not applicable · NCT01754025

INHERIT EGFR - Studying Germline EGFR Mutations

Lung cancer is a common malignancy that is associated with cigarette smoking but can also affect individuals who never smoked. It is not well understood whether there are hereditary risk factors that influence the risk of lung cancer. It has been recently found that a small number of families have an inherited (passed from parent to child) change in one of their genes that may contribute to an increased tendency to develop lung cancers, even in never smokers. In some lung cancer patients this gene, called "EGFR", contains a DNA change known as an "inherited EGFR mutation". Early data indicate that these inherited EGFR mutations may be associated with an increased risk of lung cancer. So far, only a small number of families have been found to carry inherited EGFR mutations. For this reason the risk of lung cancer associated with inherited EGFR mutations is not well understood. Understanding the risk may help investigators find ways of detecting lung cancer sooner or reducing the risk of developing lung cancer. It was recently discovered that lung cancer patients who are found to carry one rare EGFR mutation in their cancer cells, called "T790M", have an increased risk of carrying an inherited EGFR mutation in their normal cells as well. This represents a new strategy for finding individuals and families carrying inherited EGFR mutations. This research study is designed to find cancer patients whose tumors have this EGFR mutation, T790M, to find out if they also have an inherited EGFR mutation. Subjects will not have to undergo a biopsy to participate in this research study. Investigators will collect a saliva specimen from patients with a T790M in their cancer to find out if they also have an inherited EGFR mutation. Study participants found or known to carry an inherited EGFR mutation will have the option of offering their close relative the opportunity to also participate in this study. Close relatives can consider testing to see if they also carry the inherited mutation in their normal cells. Once investigators have identified individuals and relatives that carry inherited EGFR mutations in their genes, investigators will then try to understand the risk of lung cancer and other cancers. Individuals with inherited EGFR mutations will also have the opportunity to participate in future studies related to cancer and other diseases. This study is being funded in part by the Conquer Cancer Foundation of ASCO and the Bonnie J. Addario Lung Cancer Foundation.

EGFRObservational
Recruiting · Not applicable · NCT05265429

Biology of Young Lung Cancer Study: The YOUNG LUNG Study

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

Non-small cell lung cancer (NSCLC)Small cell lung cancer (SCLC)Observational
Recruiting · Not applicable · NCT00451022

Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies

This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup. The study does not involve the use of any drug or biologic agent. Participants will undergo an annual health history. Because certain viruses enter into cells and create proteins from the viral genes, the type of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral vectors do not become part of the genetic material left behind. Because gene therapy is a somewhat new technology, a prolonged monitoring of patients' health status is necessary, according to new specific reporting requirements for harmful events in patients who undergo such gene therapy studies. The risk of any long-term negative effects from the gene therapy that patients had received is quite small. Still, it is important that there be updates at least annually. This annual monitoring of health status will extend for 15 years, according to guidelines from the Food and Drug Administration, or for as long as patients are willing to participate. Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology, may be eligible for this study. Participants will be involved in the following forms of data collection: * Annual medical history and physical examinations for the first 5 years following the last vaccine. * Annual telephone contact during the last 10 years. * Health status check, including primary cancer status, secondary malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. * Blood tests for the presence of HIV antibodies. * Reporting of medical problems, including information on unexpected hospitalizations and medications. If a participant has died, the study will document the cause of death and autopsy information if available.

Cell or gene therapyObservational
Recruiting · Not applicable · NCT07168993

Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.

Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.

DiagnosticInterventional
Recruiting · Not applicable · NCT07733141

Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease

This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.

Supportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Recruiting · Not applicable · NCT01441089

Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis

Background: \- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes. Objectives: \- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment. Eligibility: \- Individuals with cancer who are being treated at the National Cancer Institute. Design: * Participants will provide a blood sample for study. * Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample. * If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.

Observational
Recruiting · Not applicable · NCT02146170

Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors

Background: \- Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it. Objective: \- To collect tissue samples for use in the study of lung cancers. Eligibility: \- Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors. Design: * Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks. * Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy. * Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine that takes pictures of the body. * After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.

Non-small cell lung cancer (NSCLC)Small cell lung cancer (SCLC)Observational
Recruiting · Not applicable · NCT00001465

Study of the Disease Process of Lymphangioleiomyomatosis

Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor. This study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy. Researchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.

Observational
Recruiting · Not applicable · NCT00034216

Collection of Blood From Patients With Cancer

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment. Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.

ChemotherapyRadiation therapySurgeryObservational
Recruiting · Not applicable · NCT01950572

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Background: * Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. * Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. * The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. * Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. * In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: * All participants age greater than or equal to 2 years with malignant mesothelioma OR * All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin * Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: * Up to 1000 subjects will be enrolled. * Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. * Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. * Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

MesotheliomaEarly-stage or resectableLocally advancedObservational
Completed · Not applicable · NCT05369611

COVID-19 Experiences in the SELF Cohort

Background: COVID-19 affected African Americans more than Whites. African Americans, especially women, have had higher rates of COVID-19 infections compared to Whites. They are also more likely to go to the hospital or die of this disease. Many researchers who looked into these issues lacked background data on the people they studied. SELF is a 10-year study of fibroids in African American women aged 23-35. Researchers already have a lot of data on these women. Asking how COVID-19 affected them can add context other studies lack. Objective: To describe the impact of the COVID-19 pandemic on young African American women and their families. Eligibility: Participants must be enrolled in SELF (Study of Environment, Lifestyle, and Fibroids). Design: Researchers will invite all women enrolled in SELF to participate in this natural history study. Participants will complete one questionnaire. They will answer the questions online. They may also choose to get a paper copy sent by mail. The survey will take no more than 15-20 minutes. All questions will relate to COVID-19. Participants will be asked if they had COVID-19. They will be asked if family, friends, or members of their community did. They will answer questions about their vaccine status and access to health care services. Participants will also answer questions about how the pandemic affected their lives. They will be asked about their job and if finding childcare was a challenge. They will be asked about money problems and how they coped. They will be asked about sleep problems and emotional distress. Participants will get a $30 gift card after they finish the survey.

Observational
Enrolling By Invitation · Not applicable · NCT05600933

Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment

Background: Many advances have been made in cancer treatments, but more research is needed. Comparing samples of cancerous tissue to samples of normal, noncancerous tissues may help find differences between them. These differences may help researchers find new ways to treat cancer. Objective: To collect tissues and blood samples from people with known or suspected cancer. The samples will be used to help identify new targets for cancer treatments. Eligibility: People aged 18 years and older with a known or suspected cancer that requires surgery or biopsy. Design: Participants will be screened. They will answer questions about their health. They can do this on the phone or in person. Researchers will collect information from participants medical records. Data may include information about any prior or current cancers. Data about other medical conditions may also be collected. Participants will have blood drawn. Some of the blood will be tested for HIV and hepatitis B and C. Some of the blood will be used for genetic research. Participants will have tissue samples collected during surgeries or biopsies. These are procedures the participants would have had as part of their standard care. No new procedures will be done just for this study. Researchers may also seek out samples from prior procedures the participant had done. Participants will remain in the study for 6 months. They may have blood drawn again. Researchers may also collect tissue samples from any procedures performed during that time.

SurgeryObservational
Recruiting · Not applicable · NCT07615764

An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial

This clinical trial evaluates the acceptability and effectiveness of an educational intervention (Lung Toolkit) for improving knowledge about lung cancer and lung cancer screening among American Indian/Alaskan Native (AI/AN) cigarette smokers. The Lung Toolkit is an educational intervention, including a website and a physical artifact pouch, specifically tailored to the needs of AI/AN individuals. The website includes evidence-based resources about lung health and lung cancer screening, facts about commercial tobacco and traditional tobacco, national and local smoking cessation and screening resources, and community-building resources such as stories from AI/AN community members about their experiences with lung cancer screening and smoking cessation. The physical artifact pouch links to the website with a quick response code and contains ceremonial herbs and motivational messaging around smoking cessation and lung cancer screening. The Lung Toolkit intervention may be effective for improving knowledge about lung cancer and lung cancer screening among AI/AN cigarette smokers.

PreventionInterventional
Enrolling By Invitation · Not applicable · NCT00068003

Harvesting Cells for Experimental Cancer Treatments

Background: The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product. Eligibility: Patients must be eligible for a NCI Surgery Branch Treatment Protocol Normal Volunteers must meet the criteria for blood donation Design Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol. There is no required follow up for normal volunteers.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVSurgeryObservational
Terminated · Not applicable · NCT05124743

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors

This is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type: * Gynecologic cancer (ovarian or endometrial) * Colorectal cancer * Pancreatic cancer * Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas * Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Alaunos Therapeutics Inc.'s (Alaunos) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol. Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.

Non-small cell lung cancer (NSCLC)Recurrent or relapsedCell or gene therapyObservational
Recruiting · Not applicable · NCT00242723

Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining

Background: * Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein. * Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in participants. * A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them. Objectives: * To medically evaluate individuals with potential (medically suspicious) or proven cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, and then, to determine eligibility for NCI investigational treatment studies for participants \>18 years of age (adult participants only). * To use clinically obtained biopsies (small pieces of tissue) of tumor and adjacent normal tissue from clinically indicated procedures (standard of care biopsy or surgery), as well as blood and urine samples, from participants with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, for research into immune and cellular changes of these cancers. Study research includes genetic testing and the growth of laboratory cell lines from participant samples, to examine how genes change drug metabolism. * To permit long-term follow-up of participants with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, for natural history research on genetics and if the gene expression coincides with clinical response to patient anti-cancer therapies (treatment received at NCI or from participant's own physicians). Eligibility: * Individuals 2 years of age and older with potential (medically suspicious) or proven cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung. Note: Individuals \>= 2 years of age and under 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood or urine does NOT add risk to the clinically indicated procedures. * Participants must have physical examination parameters within acceptable limits by standard of practice guidelines prior to clinically indicated surgical procedure (standard of care biopsy or surgery). Design: * All participants will undergo standard tests to evaluate the stage of their disease, and then, eligibility determination for NCI investigational treatment studies will be made for participants \>18 years of age (adult participants only). * Participants \>18 years of age (adult participants only) who are determined to be eligible for a treatment study at NCI are offered participation in that study. No investigational treatment is administered on this protocol. * Participants \>= 2 years of age (all participants) may receive standard of care treatment at NCI or with their own physician if it is determined that standard of care surgery, radiation, or chemotherapy is more clinically appropriate for that participant's disease status. * Participants who receive standard of care biopsy or surgery (clinically indicated standard staging, surgical intervention, and follow up care) at the NIH Clinical Center are expected to return for a clinical examination visit post-procedure (for instance, 4 weeks after discharge from surgery). After recovery, participants will return to the NIH Clinical Center for study follow-up visits at intervals based on their clinical status (such as every 3 to 36 months) until the end of study participation. * Blood and urine samples are collected from all participants for study research at baseline and study visits until the end of study participation. If participants have additional clinically indicated biopsies or surgeries, resected tissue may be collected for study research (as logistically appropriate). * It is expected that up to 1,559 participants will be enrolled and followed long-term on this study.

MesotheliomaChemotherapySurgeryObservational
Active Not Recruiting · Not applicable · NCT07485179

Emulation of the KEYNOTE-042 (NCT02220894) Trial Using Specialty Oncology Electronic Health Records Databases

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVImmunotherapyChemotherapyObservational
Active Not Recruiting · Not applicable · NCT07485166

Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases

Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies.

Non-small cell lung cancer (NSCLC)ImmunotherapyChemotherapyObservational
Completed · Not applicable · NCT07164404

Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients

Investigators are evaluating an EHR-based, non-interruptive alert to increase NRT prescribing in the hospital and at discharge for hospitalized patients. Investigators will investigate two randomized groups of resident physicians to evaluate their prescribing behaviors when the tool is introduced.

Health Services ResearchInterventional
Active Not Recruiting · Not applicable · NCT03621813

Exercise Rehabilitation in Veteran Cancer Survivors

Exercise rehabilitation has the potential as a non-pharmacological approach to reduce persistent neuropathic pain in Veterans with lung cancer. By examining the effects of exercise training in Veteran cancer survivors with NSCLC, there is the potential to revolutionize care for a: common, debilitating, and inadequately treated symptom in a growing population. This could lead to a larger investigation to fill critical gaps in the literature and at the same time help discover a new model of care for Veterans with chronic pain. The ultimate goal is to reduce this type of pain for the growing population of cancer survivors while simultaneously reducing the need for problematic opioid management.

Non-small cell lung cancer (NSCLC)Supportive or behavioral careTreatmentInterventional
Active Not Recruiting · Not applicable · NCT05491213

TELESCOPE- TELEhealth Shared Decision-making COaching

Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict. Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers. Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).

Supportive or behavioral careScreeningInterventional
Recruiting · Not applicable · NCT03774758

Biomarkers for Risk Stratification in Lung Cancer

This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.

Non-small cell lung cancer (NSCLC)Observational
Recruiting · Not applicable · NCT06228209

Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer

TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no/mild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.

METSupportive or behavioral careHealth Services ResearchInterventional
Available · Not applicable · NCT07783009

An Expanded Access Program to Provide Divarasib to Participants With Previously Treated KRAS G12c-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this expanded access program (EAP) is to provide early access to divarasib to participants with KRAS G12C-positive (KRAS G12C+) advanced or metastatic non-small cell lung cancer (NSCLC), prior to divarasib becoming commercially available in the United States.

Non-small cell lung cancer (NSCLC)KRASMetastatic or stage IVExpanded AccessAfter prior treatment
Not Yet Recruiting · Not applicable · NCT07869329

Biomarker Testing to Predict Radiation-Related Heart Disease in Lung Cancer Patients

The study will measure serum Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) levels in adults with non-small cell lung cancer receiving hypofractionated radiation therapy and evaluate whether these biomarkers correlate with radiation dose to the heart, cardiac dysfunction, and adverse cardiac events. Participants will undergo blood collection and echocardiography over a two-year follow-up period.

Non-small cell lung cancer (NSCLC)Radiation therapyDiagnosticInterventional
Recruiting · Not applicable · NCT03551951

Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow

Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage. Circulating and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies and improve screening.

Non-small cell lung cancer (NSCLC)Early-stage or resectableRecurrent or relapsedSurgeryObservational
Recruiting · Not applicable · NCT06717334

A Study of Lung Cancer Screening in People With Unexplained Weight Loss

The researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.

Observational
Recruiting · Not applicable · NCT07690917

A Study of a New PET Scanner in People With Cancer

The researchers are doing this study to test the capabilities of a new total-body PET scanner called the Biograph Vision Quadra. The researchers want to learn whether this scanner can produce better PET/CT images and provide more useful imaging information than standard PET/CT scanners.

Non-small cell lung cancer (NSCLC)Observational
Recruiting · Not applicable · NCT06957314

A Study of Hospital-at-Home for People Receiving Tarlatamab

The purpose of this study is to find out whether a Hospital-at-Home (HaH) program is a more efficient way to monitor people's health after receiving tarlatamab than monitoring in the hospital (inpatient).

Small cell lung cancer (SCLC)Health Services ResearchInterventional
Recruiting · Not applicable · NCT07177846

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVSupportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT00471978

DNA Analysis of Blood and Tissue From Patients With Lung Cancer

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Observational
Recruiting · Not applicable · NCT06080061

Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

The purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (HART) to treat locally advanced lung cancer. Depending on the location and size of the tumor.

Locally advancedRadiation therapyTreatmentInterventional
Recruiting · Not applicable · NCT04783168

Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study

This clinical trial evaluates the relationship between walking and sleeping habits and surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased or less severe complications. Learning about how much patients walk may be important in improving outcomes after surgery. Information gained from this trial may help researchers develop interventions to improve outcomes after surgery and improve overall quality of life after surgery in patients with lung cancer.

SurgerySupportive CareInterventionalAfter surgery (adjuvant)Survivorship and quality of life
Recruiting · Not applicable · NCT04474301

Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic

The primary purpose of this study is to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of health-related quality of life and other areas such as COVID-19 specific psychological distress, and disruptions to health care, finances and social interactions. We will also evaluate the extent to which resiliency factors such as social support, perceived benefits under times of stress, and ability to manage stress may buffer associations between COVID-19 experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire that taps into these areas and is based on prior work addressing concerns of other pandemics or national crises. Participants will have previously consented to protocol PA15-0336 and have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data with prior existing data.

ObservationalSurvivorship and quality of life
Recruiting · Not applicable · NCT06743308

Novel INPUT Screening Tool to Improve Illness Understanding in Patients With Metastatic or Incurable Lung Cancer

This clinical trial compares the use of a new screening tool designed to evaluate patients' information needs, preferences, and illness understanding to the usual care to improve illness understanding in patients with lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or for which no curative treatment is currently available (incurable). Goal concordant care is a model of care that aligns a patient's medical care with their values, preferences, and goals. Often, patients may not fully understand their illness and prognosis, but this information is important so that they can make fully informed decisions regarding their care that are consistent with their values, preferences, and goals. Completing the Information Needs, Preferences, and Understanding Trial (INPUT) screening tool may allow for more frequent and regular discussions regarding disease status and treatment goals, ultimately resulting in improved patient illness understanding and goal concordant care for patients with metastatic or incurable lung cancer.

Metastatic or stage IVSupportive CareInterventional
Recruiting · Not applicable · NCT04169542

Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

SurgeryObservational
Recruiting · Not applicable · NCT05456841

Empathic Communication Skills (ECS) Training

Research indicates that perceived stigma within medical encounters is prevalent and problematic for lung cancer patients' well-being and quality of cancer care. Promoting empathic communication appears to be a potentially effective intervention target to help reduce patients' perceptions of stigma within clinical encounters; however, no formal trainings exist that focus on teaching empathic communication to oncology care providers (OCPs). Building upon favorable findings from a prior R21 (R21CA202793) and the importance of developing interventions to address lung cancer stigma, our goal is to conduct a national trial of empathic communication skills (ECS) training to facilitate improvements in the medical and psychosocial care of patients through de-stigmatizing interactions with OCPs for patients diagnosed with lung cancer.

Supportive or behavioral careInterventional
Active Not Recruiting · Not applicable · NCT05384769

Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer

This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.

ScreeningInterventional
Recruiting · Not applicable · NCT06418204

Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics

This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.

Non-small cell lung cancer (NSCLC)ImmunotherapyChemotherapyObservational
Active Not Recruiting · Not applicable · NCT04430725

Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study

This study compares the outcomes and safety of two standard treatment options called microwave ablation and surgical wedge resection in patients with non-small cell lung cancer, sarcoma and colorectal cancer that has spread to other parts of the body (metastatic). Microwave ablation is designed to kill tumor cells by heating the tumor until the tumor cells die. A wedge resection is a procedure that involves the surgical removal of a small, wedge-shaped piece of lung tissue to remove a small tumor or to diagnose lung cancer. Comparing these two treatment options may help researchers learn which method works better for the treatment of non-small cell lung cancer, metastatic sarcoma, and metastatic colorectal cancer.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedMetastatic or stage IVSurgery
Completed · Not applicable · NCT04662645

Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers

This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.

Locally advancedMetastatic or stage IVRecurrent or relapsedSupportive or behavioral careSupportive Care
Recruiting · Not applicable · NCT02596490

Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners

Objectives: Our specific aims are to: Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners. Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes.

Metastatic or stage IVSupportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Recruiting · Not applicable · NCT07220096

Registry Trial and Needs Assessment of Patients With Young-onset Lung Cancer: Impact of a Dedicated Care Program on Patient Experience and Outcomes

The goal of this research study is to learn about: The effect of enrolling in the YOLC program on patient satisfaction with care provided, The needs of patients younger than 50 with lung cancer and their family, and The impact of participating in peer support networks on these patients.

Observational
Recruiting · Not applicable · NCT07584239

Prehabilitation Physical Therapy and Relaxation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery, ROAR-LCS Trial

This clinical trial tests two different physical therapy and relaxation interventions, one in-person and at-home called Resiliency and Operative Success for Adults Receiving Lung Cancer Surgery (ROAR-LCS) and one virtually called BeFitMe. These programs that take place before and after standard of care lung cancer surgery, called prehabilitation programs, promote resiliency and patient outcomes (operative success) for adults receiving lung cancer surgery. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status after surgery. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve physical and emotional recovery including a potential shortened hospital stay for patients receiving surgery for lung cancer. Starting these intervention programs early alongside cancer treatment can improve symptoms, improve functional status and quality of life, help with emotional needs of patients, improve recovery time, and may even prolong life. ROAR-LCS and BeFitMe may promote resiliency and operative success for adults receiving lung cancer surgery.

Non-small cell lung cancer (NSCLC)Early-stage or resectableSurgerySupportive or behavioral careSupportive Care
Suspended · Not applicable · NCT05028621

Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease

The purpose of this study is to use agnostic genomic evaluation using whole exome sequencing (WES) of a variety of rare hematologic diseases grouped under rare blood diseases and its variants to further elucidate the understanding of the chemistry of these disorders and identify potential actionable mutations that can be targeted with therapies in the context of clinical trials.

ScreeningInterventional
No Longer Available · Not applicable · NCT07535359

Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer

The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.

Small cell lung cancer (SCLC)Expanded Access
Completed · Not applicable · NCT04465214

Mobile Sensor Technologies to Assess General Symptomology of People With Cancer

Background: Many digital devices, such as smartphones and activity monitors, have sensors to collect and track health data. Researchers believe these devices may be able to transform the quality of clinical research and healthcare. They believe they may be able to help assess the symptoms, response to therapy, and quality of life of people with cancer. Objective: To collect data from people with cancer using an Apple iPhone alone or together with an Apple Watch in order to assess their symptoms and activity levels. Eligibility: People ages 18 years and over who have cancer and receiving treatment for their cancer in another NIH protocol Design: Participants will be screened with their medical records. Participants will have a baseline visit. They will have visits every 2 4 weeks based on the treatment protocol in which they are co-enrolled. Then they will have a follow-up visit 4 months after the baseline visit. Visits include: Medical history Physical exam Karnofsky Performance Scale/Eastern Cooperative Oncology Group performance status to see how their disease affects daily activities The study team will use an iPhone to collect data. This includes a 6-minute walk test and tests of hearing, reaction time, and cognitive status. Questionnaires If participants have an iPhone, an Apple Watch will be provided to them after training at the baseline visit. Continuous measurement of their activity will be recorded by the watch between 2 visits. They will wear the watch while they are on study. They will wear the watch while it is not being charged. They should charge the watch at night time. They will have the watch for 4 months.

ObservationalSurvivorship and quality of life
Recruiting · Not applicable · NCT06995898

The Vanguard Study: Testing a New Way to Screen for Cancer

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).

ScreeningInterventional
Active Not Recruiting · Not applicable · NCT03731585

Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment

This trial studies how well online psychosocial intervention works in improving social well-being and support in women who are undergoing treatment for stage I-IV non-small cell lung cancer. Psychosocial intervention techniques, such as mindfulness, compassion, and emotional processing, may improve distress and help patients manage symptoms related to non-small cell lung cancer.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedMetastatic or stage IVSupportive or behavioral care
Recruiting · Not applicable · NCT03948100

Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers

This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and/or their caregivers.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedMetastatic or stage IVRadiation therapy
Enrolling By Invitation · Not applicable · NCT07838519

Personalizing Veterans' Lung Cancer Screening and Diagnosis

Lung cancer screening with low-dose chest computed tomography (CT) is currently recommended for high-risk individuals who are 50 to 80 years old, have smoked cigarettes for at least 20 pack-years, and currently smoke or quit smoking within the past 15 years. In a prospective cohort at Nashville, Denver, Louisville, Chicago, Kansas City, Salisbury and Seattle Veteran Affairs medical centers, the investigators will evaluate the detection of lung cancer using an expanded screening eligibility criteria based on Veterans' personal and service-related exposures compared to standard of care criteria. Screening a larger population will increase the number of lung nodules needing clinical management and these nodules may or may not be cancer. In a population of Veterans with positive screenings at Nashville, the investigators will also validate a combination biomarker-based approach to manage screen-detected lung nodules to reduce time to lung cancer diagnosis and use of invasive procedures. This study will also convene a Veteran Community Advisory Board and interview Veterans to better understand their thoughts about lung cancer screening and preferences for outreach and engagement.

ScreeningInterventional
Active Not Recruiting · Not applicable · NCT04305613

Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy

This observational cohort will evaluate the cardiovascular effects of chemoradiation used to treat locally advanced, non-small cell lung cancer. Patients will be enrolled prior to the start of therapy and followed during and for at least 2 years after therapy with echocardiograms, nuclear stress tests, blood sampling, and quality of life surveys.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedRadiation therapyObservational
Active Not Recruiting · Not applicable · NCT06332131

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.

Non-small cell lung cancer (NSCLC)ImmunotherapyObservational
Active Not Recruiting · Not applicable · NCT06213532

CONNECTing to LungCare

This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.

Supportive or behavioral carePreventionInterventional
Recruiting · Not applicable · NCT06037954

A Study of Mental Health Care in People With Cancer

The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.

Interventional
Active Not Recruiting · Not applicable · NCT04314401

National Cancer Institute "Cancer Moonshot Biobank"

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

Non-small cell lung cancer (NSCLC)Locally advancedMetastatic or stage IVObservational
Recruiting · Not applicable · NCT07795411

Prospective Multiomic Analysis in Small-Cell Lung Cancer

This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receiving standard of care commercial DLL3 T cell engager. The goal of the study is to understand the changes in tumor markers over time and examine whether these changes are associated with clinical outcomes. Participants will provide blood samples and, when clinically feasible, tumor tissue during routine care visits, treatment, and imaging assessments. The study does not assign cancer treatment.

Small cell lung cancer (SCLC)Recurrent or relapsedObservational
Completed · Not applicable · NCT02243748

Palliative Care Intervention in Improving Symptom Control and Quality of Life in Patients With Stage II-IV Non-small Cell Lung Cancer and Their Family Caregivers

This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.

Non-small cell lung cancer (NSCLC)Early-stage or resectableMetastatic or stage IVRecurrent or relapsedSupportive or behavioral care
Recruiting · Not applicable · NCT06432985

Smoking Cessation CM for Veterans With or at Risk for Cancer

Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.

Supportive or behavioral careTreatmentInterventional
Not Yet Recruiting · Not applicable · NCT07599943

Population Health Management -Increase Lung Cancer Screening in Community Health Centers (LungSMART)

The long-term goal of Lung Sequential Multiple Assignment Randomized Trial (LungSMART) Utah is to increase the reach of Low-Dose Computed Tomography (LDCT) screening for lung cancer (hereafter referred to as Lung Cancer Screening or LCS) at scale in low-resource healthcare settings.

Supportive or behavioral carePreventionInterventional
Recruiting · Not applicable · NCT07059884

Distance-Based Exercise to Preserve Function and Prevent Disability

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

Supportive or behavioral careSupportive CareInterventional
Active Not Recruiting · Not applicable · NCT00339495

Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial

The Division of Cancer Preventionl (DCP, formerly DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About, 74,000 men and 74,000 women, aged 55-74 years, have been randomized on a 50/50 basis into screening or usual care arms. Additional blood is collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues are obtained for selected cases that develop cancer or selected related diseases (e.g. colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and disease-related information is also collected, withconfirmation of disease status from medical records. Genetic, biochemical and questionnairebasedrisk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. In 2009 the NCI Executive Committee approved the Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants will be reconsented for the release of records to a single NCI-Designated Central Data Collection Center (CDCC), which will administer the annual mailings containing the annual study update questionnaire and a brief (1-2 page) risk factor questionnaire. Individuals who do not consent to release their identifiers to the CDCC will be followed up passively through linkage to state cancer registries and the National Death Index. This protocol Review Application is for (1) the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies and (2) the coordination, in collaboration with DCP, of the Extended Follow-up.

Observational
Recruiting · Not applicable · NCT05334069

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

Early-stage or resectableLocally advancedMetastatic or stage IVObservational
Active Not Recruiting · Not applicable · NCT03939481

Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedChemotherapyObservational
Completed · Not applicable · NCT01846520

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.

Early-stage or resectableLocally advancedMetastatic or stage IVRecurrent or relapsedSupportive or behavioral care
Active Not Recruiting · Not applicable · NCT05987189

Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

SurgeryObservational
Completed · Not applicable · NCT06245876

Lung EpiCheck Biomarkers Development Study

This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.

Early-stage or resectableObservational
Active Not Recruiting · Not applicable · NCT06630429

A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors

A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. The primary objective of the study is to determine whether baseline TFx can be reliably predicted in patients with NSCLC and RCC and if changes can be detected during treatment that may correlate with response. Exploratory analyses will be completed to assess the potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy. Measurements will include circulating IL-6 and other cytokine levels, glucocorticoid levels, ketone levels and stool analysis for assessment of gut microbiome.

Non-small cell lung cancer (NSCLC)ImmunotherapyObservational
Active Not Recruiting · Not applicable · NCT03391362

Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases

This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases. The intervention involved in this study is: -Stereotactic (focused, pinpoint) radiation

Small cell lung cancer (SCLC)TreatmentInterventionalBrain metastases
Recruiting · Not applicable · NCT07460440

SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier

The purpose of this study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses lung cancer. Using retrospective platelet transcriptomic data from 522 patients with non-small cell lung cancer (NSCLC, the most common type of lung cancer), an approach that appears to accurately classify lung cancer has been developed. The study will build upon these retrospective analyses to prospectively recruit patients with newly diagnosed lung cancer, obtain platelet RNA samples from whole blood, and perform validation analyses. This research will also test whether this approach accurately distinguishes benign from malignant lung nodules.

Non-small cell lung cancer (NSCLC)Observational
Recruiting · Not applicable · NCT06919874

Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery

The goal of the trial is to test the usability, feasibility and acceptability of an unsupervised, appbased yoga program for participants undergoing thoracic RT and their caregivers.

Non-small cell lung cancer (NSCLC)Radiation therapySupportive or behavioral careSupportive CareInterventional
Active Not Recruiting · Not applicable · NCT06383988

A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources

Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer.

Early-stage or resectableLocally advancedMetastatic or stage IVSupportive or behavioral careSupportive Care
Recruiting · Not applicable · NCT07124000

DESTINY-PANTUMOUR04

This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US

Small cell lung cancer (SCLC)HER2Early-stage or resectableLocally advancedMetastatic or stage IV
Not Yet Recruiting · Not applicable · NCT07839325

MIND-WELL Intervention

Lung cancer patients often go through more than one type of treatment, such as chemotherapy, radiation, and immunotherapy. These treatments can lead to several transition periods, which may increase stress and leave some needs unmet for patients and their family caregivers. The purpose of this study is to find out whether a program that includes mindfulness (stress reduction) and education is helpful, acceptable, and practical for lung cancer patients and their family caregivers. We also want to learn if this program helps them feel better prepared during these transitions.

ImmunotherapyChemotherapySupportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT06605404

Pan-tumor MRD Study

The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back. Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedObservational
Recruiting · Not applicable · NCT06037941

Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma

The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure how people respond to standard treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose breathprints change over time as people receive standard treatment for MPM. They will also look at how changes in people's E-Nose breathprints compare to changes in their standard imaging scans and in biomarkers of MPM in their blood.

MesotheliomaDiagnosticInterventional
Active Not Recruiting · Not applicable · NCT02293954

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may help find and diagnose CEA positive cancer that may not be detected by standard diagnostic methods.

Metastatic or stage IVDiagnosticInterventional
Active Not Recruiting · Not applicable · NCT05717998

Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy

This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. This study determines if any changes in the heart muscle can be detected either during the course of radiation therapy or shortly thereafter using specialized imaging techniques or blood tests. Cardiac magnetic resonance imaging may be used to help provide information about changes in the heart structure and function following radiation therapy. Positron emission tomography looks at differences in how the heart takes up radioactive sugar which is injected into the vein to assess changes in heart function following radiation therapy. This study may help identify patients at risk of heart issues following radiation therapy to the chest and ultimately help in the development of more effective and safe treatments for cancer in the future.

Non-small cell lung cancer (NSCLC)Radiation therapyObservational
Recruiting · Not applicable · NCT06424327

A Registry for People With Lung Cancer

Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.

Early-stage or resectableSurgeryObservationalBefore surgery (neoadjuvant)After surgery (adjuvant)
Recruiting · Not applicable · NCT07661966

Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade

This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy. This trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application. There is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy. The idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.

Non-small cell lung cancer (NSCLC)ImmunotherapyChemotherapyInterventional
Active Not Recruiting · Not applicable · NCT06337552

High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.

Non-small cell lung cancer (NSCLC)Locally advancedImmunotherapySupportive CareInterventional
Recruiting · Not applicable · NCT07028489

Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer

The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (\~30%) will undergo imaging with standardized intervals.

Non-small cell lung cancer (NSCLC)EGFRLocally advancedMetastatic or stage IVTargeted therapy
Recruiting · Not applicable · NCT07168629

A Community Health Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers

Lung cancer screening (LCS) can reduce lung cancer-related mortality, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer screening and tobacco treatment utilization. Participants are randomized to enhanced usual care, a community health worker (CHW)-delivered intervention, or the same intervention delivered by a trained lay navigator. The intervention includes patient outreach, patient-centered shared decision-making, tobacco treatment counseling, and assistance navigating logistical barriers to care. The proposed activities will lay the groundwork for a subsequent fully powered randomized clinical trial evaluating CHW- and lay navigator-delivered approaches to facilitate access to lung cancer screening and tobacco treatment.

Supportive or behavioral careHealth Services ResearchInterventional
Active Not Recruiting · Not applicable · NCT06008574

A Study Comparing Mindfulness Apps to Decrease Anxiety in People With Lung Cancer

The purpose of this study is to find out if it is practical to provide the program contained within the smartphone app AmDTx before and after lung cancer surgery. AmDTx is a platform that re-configures according to the specific needs of patients through physician prescriptions.

SurgerySupportive CareInterventional
Recruiting · Not applicable · NCT07564960

Social Optimization Study

This study tests whether clinical interventions to optimize support receptivity lead to improvements in social integration and quality of life (QOL) amongst long-term lung cancer survivors. The feasibility and acceptability of the intervention and assessment procedures will be examined. Thirty long-term lung cancer survivors will be randomized to a support receptivity intervention or an attention-control condition. Our intervention draws on cognitive behavioral therapy (CBT) strategies to reduce social anxiety, improve social awareness, and promote social integration. We will use two novel in vivo sampling methods using a mobile phone platform to assess social engagement and QOL improvements: 1) recording via the Electronically Activated Recorder to capture daily social interactions, and 2) repeated self-report sampling where participants answer questions about their social engagement experiences via their personal cell phone.

Supportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Recruiting · Not applicable · NCT07711691

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)

Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can reduce the risk of dying from lung cancer, but many people who are eligible for screening do not receive it. The purpose of the Empower LCS/Call+ study is to evaluate new strategies to improve lung cancer screening among adults who are eligible for screening based on current U.S. Preventive Services Task Force (USPSTF) guidelines. This pilot randomized controlled trial will enroll approximately 80 participants from UC Irvine Health and Emory Healthcare. Participants will be randomly assigned to receive either enhanced usual care or the Empower LCS/Call+ intervention. The intervention includes educational materials, reminders for patients and primary care providers, and information about financial and community resources when appropriate. Participants who do not complete lung cancer screening after the initial intervention may receive additional telephone-based navigation through the Call+ program to help identify and address barriers to screening and help with scheduling. Participants will complete a baseline survey and follow-up surveys at 4 and 8 months, and researchers will review electronic health record information to determine whether lung cancer screening was discussed, ordered, and completed. Some participants will also be invited to complete a one-time interview about their experiences with the study. The results of this study will help determine the feasibility, acceptability, and preliminary effectiveness of the Empower LCS/Call+ intervention and will inform future efforts to improve equitable access to lung cancer screening.

Supportive or behavioral careHealth Services ResearchInterventional
Enrolling By Invitation · Not applicable · NCT04291755

Development and Analysis of a Stool Bank for Cancer Patients

This study is aimed at understanding the impact of gut microbiota on efficacy of cancer therapies, in particular checkpoint inhibitors, and using the resulting information to design microbial immunotherapies. Although animal models are of use to determine the influences of gut and other microbiota on cancer treatment modalities, they are limited due to differences between mouse and human physiology and immunology, as well as the inherent differences in gut microbial populations between the two mammalian organisms. Therefore, samples obtained as donations from human subjects undergoing cancer treatment are of great value for the identification and determination of bacteria and their metabolic processes that are involved in the successful cure and remission of cancer by checkpoint inhibitor therapies. The objective of this study is to collect 3 samples each of blood, urine, and stool in subjects with cancer. This is a non-interventional, 2 site study in 100 people who are undergoing any type of cancer immunotherapy. Subjects who meet the entry criteria will provide 5 samples each of blood, urine, and stool over a 12-month period.

ImmunotherapyObservational
Suspended · Not applicable · NCT04638751

ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment. Currently enrolling the CRC, high risk, and low risk cohorts. Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years.

Non-small cell lung cancer (NSCLC)ImmunotherapyChemotherapySurgeryObservational
Active Not Recruiting · Not applicable · NCT05863052

Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

The aim of this study is to describe the outcomes in American Indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

Metastatic or stage IVImmunotherapyObservational
Active Not Recruiting · Not applicable · NCT05952778

Reminder Messages for Lung Cancer Screening

To test lung cancer screening reminder messages to help adults who 1) 50 to 80 years of age, 2) smoke or have smoked, and 3) do not have history of lung cancer by self-report.

Observational
Active Not Recruiting · Not applicable · NCT05057676

Autoimmune Intervention Mastery Course Study

The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue.

Supportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT07824583

A Study Evaluating a New Radiation Treatment Workflow (NGDS)

The purpose of this research is to evaluate the "Next Generation Delivery System" (NGDS) and determine if this machine will be more efficient at delivering radiation in shorter treatment time and better patient tolerance, with less breath holding.

Interventional
Terminated · Not applicable · NCT05937074

Metabolic Response to Food in Lung Cancer

This goal of this study is to describe how unintentional weight loss influences fasting and post-prandial metabolic flexibility in participants with advanced non-small cell lung cancer.

Non-small cell lung cancer (NSCLC)Observational
Recruiting · Not applicable · NCT07505797

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health

AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes. The study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden. This study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.

ObservationalBefore surgery (neoadjuvant)After surgery (adjuvant)
Active Not Recruiting · Not applicable · NCT07567352

A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment

The main purpose of the study is to learn how the lung cancer medicines work. The study also looks into treatment sequence of these medicines. This study is performed outside of clinical studies in a database in the United States in patients with metastatic or advanced non-small cell lung cancer. Non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. Metastasis is when the cancer cells spread to other parts of the body. Advanced cancer is when the patient is diagnosed with stage III or stage IV cancer. This study includes patient's information from the database who: * Are aged 18 years or older. * Are confirmed to have metastatic non-small cell lung cancer on or after 1 January 2021. * Have a positive Anaplastic Lymphoma Kinase (ALK) gene mutation or rearrangement. A gene is a part of your DNA that has instructions for making things your body needs to work and a mutation or rearrangement can cause the gene not to work properly. ALK is a protein that helps control cell growth. * Received lorlatinib as their first treatment. All participants in this study had received the study medicine lorlatinib. It is a tablet that is taken by mouth at home. They continued to take the study medicine until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. The study is based on information collected from Flatiron Health's Advanced NSCLC Panoramic dataset which includes: \- Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, age, gender, etc.

Non-small cell lung cancer (NSCLC)ALKLocally advancedMetastatic or stage IVTargeted therapy
Enrolling By Invitation · Not applicable · NCT05627674

Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment

This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.

Supportive or behavioral carePreventionInterventional
Recruiting · Not applicable · NCT07490860

A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to Increase Lung Cancer Screening Among Black Community Members, RESTORE Trial

This clinical trial develops and studies whether a restorative justice-based lung cancer screening (LCS) decision-making support intervention tailored for Black individuals increases LCS among Black community members. Lung cancer remains the leading cause of cancer deaths among Black men and women. LCS with yearly low-dose chest computed tomography (CT) is recommended for people with current or recent tobacco use (within 15 years) who are aged 50-80 with at least a 20 pack-year smoking history. LCS lowers lung cancer death by 20%; however, data shows that LCS completion remains low among minority groups in the United States. The restorative justice-based LCS decision-making support intervention in this trial has been specifically tailored to meet the needs of Black individuals. It is designed to reduce racial unfairness by promoting trust, shared understanding, and empowerment in clinical decision making while addressing the social and historical circumstances of health inequalities. This may be an effective way to increase LCS among Black community members.

ScreeningInterventional
Not Yet Recruiting · Not applicable · NCT07822126

Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management

The main objective of this project is to demonstrate the potential of three new technical innovations for improving state-of-the-art bronchoscopy guidance systems. Through this study, we plan to generate preliminary data that demonstrates the potential of three new innovations for enhancing existing bronchoscopy systems in the live clinical setting. The goal is to demonstrate the potential of the new innovations: 1. to demonstrate the potential of a new methodology to reduce errors from CT-to-body divergence in the live clinical setting, 2. to demonstrate the potential of the new methodologies to enable live rerouting of a guided bronchoscopy, and 3. to perform automatic real-time mucosal lesion detection during a standard airway examination. These innovations could potentially improve current image-guided bronchoscopy systems and be used for future robotic bronchoscopy.

Observational
Completed · Not applicable · NCT05001009

Goals of Care Conversations Study

The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.

Supportive or behavioral careHealth Services ResearchInterventional
Recruiting · Not applicable · NCT05010109

Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.

Non-small cell lung cancer (NSCLC)Locally advancedSupportive or behavioral careDiagnosticInterventional
Completed · Not applicable · NCT05230186

A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.

T Cell Receptor-engineered T-cell therapy (TCR T-cell therapy) offers a potentially transformative approach to treating cancer, but is currently limited by the lack of known targets (Maus and June, 2016; Ping et al., 2018). Arguably the most clinically meaningful way to discover new targets and TCRs for TCR T-cell therapy is to study the tumor-infiltrating lymphocytes of patients that are actively responding to immune checkpoint inhibitor (ICI) therapy. These T cells are clonally expanded as a result of checkpoint inhibition and are responsible for the patient's clinical response. The goal of this study is to acquire tumor and blood samples from up to 200 patients with solid tumor malignancies who respond to ICI therapy. T cells will be isolated from these samples and the targets of their TCRs determined using TScan's genome-wide, high-throughput target ID technology. The expected outcome of this study is the discovery of a collection of new targets for TCR T-cell therapy, along with associated TCRs that will then be developed as novel therapies for patients with similar malignancies.

ImmunotherapyCell or gene therapyObservational
Withdrawn · Not applicable · NCT03804255

Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting

This trial assesses current biomarker testing practices for common solid cancers in precision oncology in the community setting. Cancer biomarkers are used for diagnosing the disease, determining prognosis, predicting response to a targeted therapy, or monitoring response to therapy. Testing quality, including accuracy and timeliness, is imperative for correct disease prognosis and identification of patients who may or may not benefit from a targeted therapy. Assessing current biomarker testing practices may help doctors identify gaps and variations in testing as well as on potential ?best practices? that may be informative and generalizable to community oncology programs.

Targeted therapyObservational
Recruiting · Not applicable · NCT06033248

Using Urine Samples to Identify Lung Cancer

The researchers are doing this study to test the ability of an animal biosensor platform (ABP) to detect NSCLC. Participants in this study will either be diagnosed with NSCLC, suspected to have NSCLC, or have not been diagnosed or suspected to have NSCLC. The ABP test uses laboratory animals that are trained to detect (by smell) different chemicals in urine. Studies show that people with lung cancer have unique chemicals in their urine that are not present in people without lung cancer, and researchers think these chemicals can be used to identify people with lung cancer without the need for invasive procedures (like biopsy).

Non-small cell lung cancer (NSCLC)Observational
Recruiting · Not applicable · NCT05059444

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

Non-small cell lung cancer (NSCLC)Early-stage or resectableRecurrent or relapsedObservational
Recruiting · Not applicable · NCT06674811

Biomarkers of Resiliency In Childhood Cancer Surgery

This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are: 1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery? 2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery? Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to: * wear a smartwatch * complete questionnaires * allow for extra blood to be drawn for this research study when they are having their regular blood draws for clinical purposes These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.

SurgeryObservationalAfter surgery (adjuvant)
Recruiting · Not applicable · NCT07391956

Tier Palliative Care For Patients With Advanced Heart Failure or Cancer

TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no/mild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.

METSupportive or behavioral careHealth Services ResearchInterventional
Recruiting · Not applicable · NCT04644952

The Rise in Robotic Atypical Segmentectomies

This study investigates the increased rate of robotic atypical segmentectomies. Segmentectomy refers to removing a section of a lobe of the lung. Reviewing patients' data retrospectively may help researchers determine whether robotic surgery has led to an increase in atypical segmentectomy.

SurgeryObservational
Active Not Recruiting · Not applicable · NCT05150210

SP Thoracic IDE Study

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.

SurgeryInterventional
Not Yet Recruiting · Not applicable · NCT07814872

A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment

Many clinical trials evaluating cancer treatments require patients to undergo testing for specific molecular markers as part of eligibility screening, typically using immunohistochemistry or sequencing. Because relatively few patients may carry a required marker, trial investigators often test large numbers of patients to identify the few who may ultimately qualify for enrollment. Pathology laboratories routinely produce hematoxylin-and-eosin (H\&E) slides during cancer diagnosis. Pathology foundation models-large neural networks pretrained on millions of histology images-have shown promise in predicting molecular characteristics from these slides. Researchers can use these models to build classifiers that predict specific molecular markers and prioritize patients for confirmatory testing. This study evaluates FATHOM (Facilitating Accrual through Tumor Histology and Omics Matching), an autonomous research system powered by large multimodal models. Its agents read registered clinical trial records, identify molecular markers used as enrollment criteria, build prediction models using pathology foundation models, select the individual models or model combinations that best meet prespecified criteria, set their decision thresholds, and determine whether to deploy them. Together, a prediction model, its decision threshold, and the decision to deploy it constitute an AI prediction policy. Before FATHOM runs, the investigators preregister the clinical trial records that its agents may read, the cutoff date that defines which trial information they may use, the rules governing the agents, and the analysis plan. The system timestamps and locks each policy immediately after an agent produces it. The investigators then apply the policies to archived patient slides and compare their predictions with existing molecular marker results. The primary outcome is the proportion of prespecified evaluation scenarios in which an agent-generated policy, compared with universal molecular testing, either enriches the population selected for confirmatory testing with marker-positive patients or safely spares patients from confirmatory testing while meeting prespecified performance criteria. This study analyzes existing pathology images and clinical trial records only. It does not enroll or contact patients, influence patient care, or affect participation in any clinical trial.

Observational
Recruiting · Not applicable · NCT05935384

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.

Non-small cell lung cancer (NSCLC)Early-stage or resectableObservational
Recruiting · Not applicable · NCT06816121

Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers

The goal of this observational study is to develop and evaluate a blood test for asymptomatic heavy smokers to screen for those at highest risk of developing lung cancer. The aim of this study is to develop, train, and validate a blood-based screening test designed to detect biomarkers associated with lung cancer. The study will utilize samples collected from 4 distinct cohorts. 1. Participants confirmed to have lung cancer 2. Participants without cancer 3. Participants with moderate risk of lung cancer (indeterminate) 4. Participants confirmed to have other types of cancers linked to smoking The main question this study aims to answer is whether the blood test can detect existing early-stage lung cancer in heavy smokers without symptoms and to provide insights into device performance and long-term outcomes when scans show no nodules, benign findings, or indeterminate nodules. Participants will provide blood samples at the start of the study and during follow-up visits at 12 and 24 months. Participants will share information about their smoking history, lung cancer status, and relevant medical history Researchers will collect blood samples, process them, and analyze the biomarkers at the Everest Detection laboratory. No results will be shared with participants or their doctors. The study will run for about 48 months, including a 24-month enrollment period and 24 months of follow-up to track participants' health and lung cancer outcomes.

Early-stage or resectableObservational
Active Not Recruiting · Not applicable · NCT01817192

Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer: AIM-HIGH (Adjuvant Intervention in Molecular High Risk Patients)

The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.

Non-small cell lung cancer (NSCLC)Early-stage or resectableMetastatic or stage IVChemotherapySurgery
Active Not Recruiting · Not applicable · NCT04739696

Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.

This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate psychological distress and pathophysiology in spousal or partnered caregivers of patients' diagnosis with a solid tumor cancer of any stage. It is expected that improving caregiver status will have reduced depressive symptoms.

Supportive or behavioral careTreatmentInterventional
Active Not Recruiting · Not applicable · NCT04905082

HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics

This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics) in improving patient knowledge of personal genomic testing results and cancer and genomics in general. HOPE-Genomics is a web-based education tool that teaches cancer/leukemia patients, and patients who may be at high-risk for developing cancer, about genomic testing and provide patients with information about their own genomic test results. The HOPE-Genomics tool may improve patient's genomic knowledge and quality of patient-centered care. In addition, it may also improve education and care quality for future patients.

Supportive CareInterventional
Recruiting · Not applicable · NCT06360822

Increasing Equity in Lung Cancer Screening

The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement.

Supportive or behavioral careHealth Services ResearchInterventional
Active Not Recruiting · Not applicable · NCT06269133

Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Participants

This multi-year cohort study will assess the real-world safety and effectiveness of first Line (1L) treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC participant subgroups defined by age, sex, race, and ethnicity. Participants will be retrospectively identified from at least two US Electronic Health Record (EHR)-based databases.

Non-small cell lung cancer (NSCLC)ChemotherapyObservational
Active Not Recruiting · Not applicable · NCT06538038

Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.

Non-small cell lung cancer (NSCLC)EGFRLocally advancedMetastatic or stage IVTargeted therapy
Active Not Recruiting · Not applicable · NCT06451003

Intervention to Improve Utilization of Extended Venous Thromboembolism Prophylaxis After Cancer Surgery

While blood clots after major cancer surgery are common and harmful to patients, the medications to decrease blood clot risk are seldom used after patients leave the hospital despite the recommendation of multiple professional medical societies. The reason why these medications are seldom prescribed is not well understood. The main questions this study aims to answer are: * Does surgeon education paired with an electronic medical record based decision support tool improve the guideline concordant prescription of pharmacologic venous thromboembolism after abdominopelvic cancer surgery? * Does dedicated patient education regarding blood clots at the time of hospital discharge after abdominopelvic cancer surgery improve understanding of the risk of venous thromboembolism and adherence to pharmacologic prophylaxis? The investigators will study these questions using a stepped-wedge randomized trial where groups of surgeons will use a tool integrated to the electronic medical record to educate them on the individualized patient risks of blood clots after major cancer surgery and inform them regarding guidelines for preventative medicines. Utilization of the medications before and after using the tool will be compared. Patients will be administered a questionnaire assessing their awareness of blood clots as a risk after cancer surgery. For those prescribed medications to reduce blood clot risk after leaving the hospital, the questionnaire will evaluate whether they took the medications as prescribed. Survey results will be evaluated before and after implementation of education on blood clot risk at the time of hospital discharge.

SurgerySupportive or behavioral careTreatmentInterventional
Recruiting · Not applicable · NCT06605534

Leveraging the Emergency Department (LEAD) Study

This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.

Supportive or behavioral careScreeningInterventional
Recruiting · Not applicable · NCT07298096

A Prospective Single Center, Single Arm, Single-institution Registry That Aims to Assess the Safety and Quality of Life Benefits of Computer-assisted Vacuum Thrombectomy (CAVT) in the Treatment of Cancer Patients With Intermediate Risk Pulmonary Embolism (PE)

The goal of this clinical research study is to gather information about the quality of life benefits of cancer patients with intermediate risk PE who underwent thrombectomy. The safety of thrombectomy in this patient population will also be studied.

Supportive CareInterventionalSurvivorship and quality of life
Active Not Recruiting · Not applicable · NCT04574518

Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules

The purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (TeaM OUT) on increasing use of smoking cessation resources in Veterans. The hypotheses are 1) patients included in the TeaM OUT group will have higher accession of cessation services, such as counseling and medication therapies, compared to patients in enhanced usual care and 2) more patients in the TeaM OUT group will have quit smoking at one year after the intervention. Veterans with a recently diagnosed lung nodule who currently smoke will receive the TeaM OUT intervention or Enhanced Usual Care. The TeaM OUT intervention has 2 parts: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit Line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources. The enhanced usual care group will receive a letter that provides information about how to contact the IVR Quit Line. The IVR system will track referrals to cessation services. Additional information about smoking status and use of cessation resources will be collected from the electronic health record and surveys.

Supportive or behavioral careHealth Services ResearchInterventional
Active Not Recruiting · Not applicable · NCT05407168

Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

Health Services ResearchInterventional
Recruiting · Not applicable · NCT06904365

Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women

Female patients with early onset (\<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.

Radiation therapyObservational
Recruiting · Not applicable · NCT05837767

A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).

Non-small cell lung cancer (NSCLC)Metastatic or stage IVRadiation therapySupportive or behavioral careTreatment
Not Yet Recruiting · Not applicable · NCT07792824

Witness Project Lung

The long-term objective is to improve lung cancer screening uptake among screening-eligible Black adults and thereby reduce the population burden of late-stage diagnosis and mortality. The short-term objective of this study is to rigorously test the effectiveness, mechanisms, and implementation readiness of Witness Project® Lung.

Supportive or behavioral careScreeningInterventional
Not Yet Recruiting · Not applicable · NCT06636721

Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer

The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults with lung cancer. The long-term goals of this research include identifying the unique concerns of these patients, providing patients with behavioral skills to address their symptom management needs, and enhancing patient engagement with healthcare specialties targeting aging-specific concerns. In the first phase of this study, participants (12 patients with lung cancer, 6 caregivers, 12 providers) will be asked to participate in two individual interviews (each 30-45 minutes in length) via teleconference. During the first interview, participants will be asked to provide feedback on the current version of the assessment and behavioral intervention. Participants will be asked to describe strengths and weaknesses of the materials, topics to add or remove, and any other suggested changes. After the research team has made changes to the materials, participants will be invited to complete a second interview to provide feedback on the updated materials. In the second phase of the study, 16 older adults with lung cancer will complete the revised assessment and participate in the behavioral intervention, in order to a) evaluate the feasibility and acceptability of the program and b) measure change in depression, anxiety, pain, and dyspnea. \*\* Phase I of the study was previously factored into the record via the overall status and start date, but the record has been revised as of 08-2026 and is now only a reflection of Phase II.

Supportive or behavioral careSupportive CareInterventional
Not Yet Recruiting · Not applicable · NCT07254650

Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1

The goal of this clinical trial is to assess how the location of local anesthetic medication affects pain control capabilities in adult patients undergoing thoracic(chest)-only minimally invasive surgery. The main questions it aims to answer are: * Is pain decreased when local analgesia is provided as a combination of serratus anterior plane block and intercostal nerve block when compared to either block administered individually? * How does location of local analgesia administration impact length-of-stay, cost-of-care, and quality-of-life? Researchers will compare three treatment options including long-acting local anesthetic (Exparel®) administered as (1) intercostal nerve block, (2) serratus anterior plane block, or (3) combination of intercostal nerve block and serratus anterior plane block to see if pain and opioid use are reduced dependent upon treatment group. All participants will receive a local anesthetic nerve block. Participants will be asked to describe their pain after surgery and to answer various questionnaires before and after surgery.

SurgeryTreatmentInterventionalAfter surgery (adjuvant)
Completed · Not applicable · NCT04670445

Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer. The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.

Non-small cell lung cancer (NSCLC)Small cell lung cancer (SCLC)MesotheliomaEarly-stage or resectableLocally advanced
Completed · Not applicable · NCT05120869

Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

Supportive or behavioral careInterventional
Recruiting · Not applicable · NCT06987890

Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy

National guidelines recommend that older adults with cancer undergo a special health assessment before starting cancer treatment. This type of assessment evaluates physical function, nutrition, social support, psychological well-being, medical conditions (both cancer-related and non-cancer-related), and cognitive function. The results can help doctors make better treatment decisions and determine whether additional support services-such as nutrition counseling, physical therapy, or social work-would be beneficial. Even though these assessments are recommended, they are not typically used because they need to be performed by a specialist and can take over an hour to complete. Given these challenges, a 10-15-minute assessment called the Practical Geriatric Assessment (PGA) was recently developed. The PGA can be completed by any healthcare provider and helps identify older adults who may need extra support alongside their cancer treatment. While the PGA has the potential to make geriatric assessments more accessible, the investigators do not yet know whether patients will find it useful or easy to complete. Additionally, it is unclear whether using the PGA will lead to more referrals for recommended supportive care services. This study aims to address these questions. The investigators will evaluate whether using the PGA impacts the number of patients referred to recommended supportive care services. Investigators will also evaluate how participants feel about completing the PGA, including how easy or difficult it is, and to assess the feasibility of implementing this survey on a larger scale. Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.

Non-small cell lung cancer (NSCLC)Radiation therapySupportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT06676956

The SEQUENCE Trial

This study will randomize participants undergoing a bronchoscopic biopsy of a peripheral pulmonary nodule for their standard of care to receive robotic-assisted bronchoscopy (RaB) and then staging linear endobronchial ultrasounnd (EBUS) OR staging linear EBUS first, followed by RaB. The goal of this study is to set the standard for optimizing the sequence of bronchoscopic procedures in patients at risk for early-stage malignancy.

Early-stage or resectableDiagnosticInterventional
Recruiting · Not applicable · NCT05041140

Hyperpolarized 129-Xenon Imaging in Adult Hematopoietic Cell Transplant Recipients With Pulmonary Impairment

This study is designed to measure the correlation of hyperpolarized 129-Xe magnetic resonance imaging (129-XeMRI) in allogeneic hematopoietic cell transplant (allo-HCT) recipients at MD Anderson Cancer Center (MDACC) who develop bronchiolitis obliterans syndrome (BOS) or BOS stage 0p (pulmonary impairment not meeting the definition for BOS, defined below) and controls with chronic graft-versus-host disease (cGVHD). The primary objective of the study is to correlate 129-Xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative CT measurements. A secondary objective is to determine whether measurement of 129-Xe MRI characteristics in patients with BOS stage 0p can predict BOS progression 6 months after enrollment.

Observational
Recruiting · Not applicable · NCT06070870

Health Education Approach to Lung Screening

Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)

Supportive or behavioral careScreeningInterventional
Recruiting · Not applicable · NCT04165798

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.

Non-small cell lung cancer (NSCLC)ImmunotherapyChemotherapyObservational
Recruiting · Not applicable · NCT06909201

Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity

The goal of this clinical research study is to learn if novel type of imaging scan called HP 129Xe MRI can help doctors identify and predict common side effects of radiation therapy. Rather than contrast-enhanced MRIs, the tracer (129Xe) will be inhaled rather than injected. The 129Xe tracer has not been FDA approved. Its use in this study is investigational.

Radiation therapyObservational
Recruiting · Not applicable · NCT05517811

Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection

The investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.

Recurrent or relapsedSurgeryObservational
Not Yet Recruiting · Not applicable · NCT07553819

Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers

This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Research suggests that daily activity reduces lung cancer risk in current and former smokers. However, current and former smokers are generally not active and new approaches to improve lung health are needed. During the home-based RMT program, participants use a handheld device to complete breathing exercise sessions consisting of breathing in and out against adjustable resistance. During the home-based AE program, participants complete aerobic exercises using a stationary bike working at a moderate workload against adjustable resistance. The home-based RMT and AE programs may be effective ways to strengthen the breathing muscles, which may improve lung health in current and former cigarette smokers.

Supportive or behavioral carePreventionInterventional
Active Not Recruiting · Not applicable · NCT04447222

Impact of the COVID-19 Pandemic and HRQOL in Cancer Patients and Survivors

This study uses questionnaires to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted health-related quality of life (HRQOL) and other areas such as COVID-19-specific psychological distress, disruptions to health care, finances and social interactions in cancer patients. The coronavirus disease 2019 (COVID-19) is an infectious disease that is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information learned from this study will guide the development of psychosocial programs to improve patient care and outcomes in cancer patients and survivors in the context of facing a global pandemic.

ObservationalSurvivorship and quality of life
Completed · Not applicable · NCT06384417

Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2

The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are: What modifications and/or adaptations are necessary to Hello for use in cancer populations? What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics? Participants will: * Complete pre-game questionnaires * Play either Hello or Table Topics game * Complete post-game questionnaires * Participate in a focus group * Complete a telephone follow up interview 1-4 months after their event This study is a continuation of NCT06028152.

Supportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT04410302

Patient-Derived Xenografts to Reduce Cancer Health Disparities

This trial establishes patient-derived cancer xenografts in addressing cancer health and treatment disparities that disproportionately affect racial/ethnic minorities. Understanding the genetic and response differences among racial/ethnic minorities may help researchers enhance the precision of therapeutic treatments.

Observational
Recruiting · Not applicable · NCT06122064

A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer

This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.

Non-small cell lung cancer (NSCLC)Early-stage or resectableLocally advancedMetastatic or stage IVHealth Services Research
Active Not Recruiting · Not applicable · NCT05064150

Neuroendocrine Tumors - Patient Reported Outcomes

With so many therapeutic options available (i.e.: biologic therapy, liver directed therapy, radiotherapy and chemotherapy), the purpose of this project is to partner with patients on comparative effectiveness research (CER) to achieve the goal of alleviating undue toxicity, and optimizing effectiveness and sequencing of therapy for neuroendocrine tumors (NET) patients. We will conduct a study of all newly occurring GEP-NET and lung NET cases aged 18 years and older diagnosed between 01/01/2018 through 09/30/2024 across 14 sites participating in the National Patient-Centered Clinical Research Network (PCORnet), enrolling an average of 215 patients per site over the 3 year study period (2515 patients total), allowing up to 60 months of follow-up for medical record outcomes. Participants will complete four online or paper surveys over 18 months; these surveys will focus on patient-reported outcomes, including questions on quality of life, treatment decisions, and experiences with cancer care. Survey data will be linked to participant medical record data to achieve study aims.

ChemotherapyRadiation therapyObservationalSurvivorship and quality of life
No Longer Available · Not applicable · NCT04667234

Expanded Access of Sotorasib

The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.

Non-small cell lung cancer (NSCLC)KRASEarly-stage or resectableLocally advancedMetastatic or stage IV
Recruiting · Not applicable · NCT07776353

Understanding New Cachexia Subtypes Through Observational Epidemiological Research

The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia. At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these malignancies carry a substantial risk of cancer cachexia, which is characterized by progressive loss of weight, muscle, and adipose tissue, accompanied by functional decline and reduced quality of life. Data collected includes demographic, physiologic, and clinical data, including tumor characteristics and biomarkers of inflammation, hormonal and metabolic status, body composition, physical function, and patient reported outcomes. Investigators will identify patient phenotypes (i.e., subgroups) that may reflect distinct biological or clinical pathways underlying cancer cachexia. By characterizing heterogeneity in cancer cachexia, this study aims to inform the development of improved diagnostic criteria and more targeted therapeutic strategies, ultimately enhancing clinical trial design and supportive care for patients with advanced colorectal, lung, or pancreatic cancer.

Non-small cell lung cancer (NSCLC)Early-stage or resectableMetastatic or stage IVTargeted therapySupportive or behavioral care
Recruiting · Not applicable · NCT07227077

Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.

Supportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT00897117

Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer. PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.

Non-small cell lung cancer (NSCLC)SurgeryObservational
Recruiting · Not applicable · NCT05787834

Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer

This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.

Supportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Not Yet Recruiting · Not applicable · NCT07768046

Multiparametric Lung MRI With Diffusion-Weighted Imaging in Lung-RADS 4 Lesion Characterization

This study evaluates whether multiparametric chest magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI), performed without any contrast material, can distinguish malignant from benign lung lesions that were assigned Lung-RADS category 4 on a standard-of-care lung cancer screening low-dose CT. Participants who have a Lung-RADS 4 lesion on screening CT undergo one non-contrast research MRI of the chest at 3.0 Tesla. The MRI is added to standard care; no standard-of-care imaging, biopsy, or treatment is withheld or replaced, and the research MRI is not used for clinical decision making. Participants then continue routine clinical management, and the final nature of the lesion is established from pathology or microbiology when tissue is obtained, or otherwise from at least 24 months of clinical and imaging follow-up. The primary measure is the sensitivity and specificity of multiparametric MRI against that final diagnosis. Secondary measures include whether DWI alone performs as well as the full MRI protocol, how MRI compares with PET/CT in participants who had PET/CT as part of their care, and quantitative MRI thresholds (apparent diffusion coefficient, lesion-to-spinal-cord signal intensity ratio, native T1 and T2). This is an exploratory pilot and feasibility study. No formal power calculation was performed; the sample size is intended to support feasibility assessment, protocol optimization, and preliminary estimates of diagnostic performance.

Observational
Recruiting · Not applicable · NCT04949464

Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study

This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.

Supportive or behavioral carePreventionInterventional
Completed · Not applicable · NCT05393154

Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy

The aim of the study is to assess the performance of Aquyre Biopsy Scanner technology (the FDA class I medical device) at determining if tissue from the lymph nodes and lung nodules, taken during a bronchoscopy procedure, is adequate for a diagnosis. The study will assess how well the Aquyre Biopsy Scanner can differentiate between tissue samples that meet certain requirements that allow for further diagnostic analysis and samples that do not.

Observational
Active Not Recruiting · Not applicable · NCT06593106

Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.

Early-stage or resectableSurgeryTreatmentInterventional
Active Not Recruiting · Not applicable · NCT06146920

Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation

The goal of this prospective study to investigate the use of circulating tumor DNA (ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell lung cancer. The main question it aims to answer is: • Do patients with metastatic melanoma or non-small-cell lung cancer, who have received at least 12 months of immune checkpoint inhibition (monotherapy or in combination) with evidence of disease response/control on imaging and have no evidence of circulating tumor DNA, have an increased 12-month disease free survival in comparison to historical controls?

Non-small cell lung cancer (NSCLC)Metastatic or stage IVImmunotherapyInterventional
Recruiting · Not applicable · NCT05463796

InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer

This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

Observational
Suspended · Not applicable · NCT07102212

Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)

This clinical trial studies whether a telemedicine-mobile health (mHealth) intervention, Finding Our Center Under Stress (FOCUS), improves symptom management in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients with advanced cancer often experience difficulties with sleep, worry, fatigue, and sometimes mood. FOCUS uses cognitive-behavioral and acceptance and commitment therapy strategies designed to improve these symptoms. Cognitive-behavioral therapy is a type of counseling focused on how the ways that people think (cognitive) and what they do (behavioral) can change the way they feel. Acceptance and commitment therapy is an intervention which has demonstrated success in treating symptoms by teaching strategies to focus time and energy on valued activities despite symptoms. This may be an effective way for patients with advanced cancer to manage their symptoms.

Supportive or behavioral careSupportive CareInterventional
Completed · Not applicable · NCT01606826

Severe Asthma Research Program

The mission of the SARP is to improve the understanding of severe asthma through integrated study of its clinical and biological features and to evaluate their changes over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.

Observational
Recruiting · Not applicable · NCT07701733

A Study of Lung Cancer Risk

The researchers are doing this study to learn more about factors that may increase the risk of lung cancer in people who have never smoked. This information may help predict which people who have never smoked may be more likely to get lung cancer.

Observational
Recruiting · Not applicable · NCT07111936

Evaluating the Impact of CONNECT in a Multilingual Population

This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.

Supportive or behavioral carePreventionInterventional
Suspended · Not applicable · NCT03987555

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

The goals of this prospective, observational cohort study are to determine the feasibility of implementing paclitaxel therapeutic drug monitoring for cancer patients and explore the relationship between paclitaxel drug exposure and the development of neuropathic symptoms. This trial studies if paclitaxel can be consistently measured in the blood of patients with solid tumors undergoing paclitaxel treatment. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nerve damage is one of the most common and severe side effects of paclitaxel. The ability to consistently measure paclitaxel in the blood may allow doctors to control the dose of paclitaxel, so that enough chemotherapy is given to kill the cancer, but the side effect of nerve damage is reduced.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVRecurrent or relapsedChemotherapyObservational
Recruiting · Not applicable · NCT07146568

Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hospital

Inspired by the ongoing Pink \& Pearl Campaign, the breast radiology service of Christian Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this campaign in its mammography clinics in order to promote awareness, referral, and completion of lung cancer screening (LCS) among eligible women. This campaign leverages established infrastructure such as nurse navigation and referral to screening or primary care for further shared decision-making on cancer screening. The purpose of this study is to evaluate the effectiveness of the Pink \& Pearl Campaign in improving LCS uptake among LCS-eligible women undergoing mammography at Christian Hospital. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, our specific aims for this proposal are to: a) assess whether the Pink \& Pearl Campaign increases referrals and uptake/completion of LCS among LCS-eligible women undergoing screening mammography; b) determine median time-to-screening after referral to LCS; and c) evaluate individual and health system factors influencing LCS uptake and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.

ScreeningInterventional
Recruiting · Not applicable · NCT06898333

Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening

The investigators proposal is ripe for executing as the investigators seek to leverage this "natural experiment" initiated by the BJC health system to evaluate the effectiveness of the Pink \& Pearl Campaign as an implementation strategy to promote lung cancer screening (LCS) uptake among LCS-eligible women undergoing mammography at BJC West County. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, the research questions and specific aims for this proposal are to: a) evaluate the baseline prevalence of LCS among LCS-eligible women; b) assess whether the Pink \& Pearl Campaign increases referrals and uptake/ completion of LCS among LCS-eligible women undergoing screening mammography; and c) evaluate individual and environmental factors influencing LCS uptake, and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.

Observational
Recruiting · Not applicable · NCT04913311

Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer

This study looks at the side effects of chemotherapy and radiation (chemoradiation) followed by immunotherapy in patients with non-small cell lung cancer, with a particular focus on lung inflammation (pneumonitis). By collecting blood, stool and saliva samples, and data from lung function tests, researchers may be able to create a database of information about treatment and side effects in patients with non-small cell lung cancer who are receiving chemoradiation followed by immunotherapy. The information gained from this study may also help researchers find signs of problems with lung function earlier rather than later, since lung function is checked more often than routine care. This may improve how quickly these issues can be treated, and future patients may benefit from what is learned.

Non-small cell lung cancer (NSCLC)ImmunotherapyChemotherapyRadiation therapyObservational
Completed · Not applicable · NCT06389981

Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening

Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans. Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 5 group lung cancer screening orientations in community partner sites to reach up to 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans.

ScreeningInterventional
Recruiting · Not applicable · NCT03422302

Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer

This pilot phase I/II trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.

Metastatic or stage IVRadiation therapySupportive CareInterventional
Recruiting · Not applicable · NCT06567704

Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study

The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.

Non-small cell lung cancer (NSCLC)ImmunotherapySupportive or behavioral careObservational
Recruiting · Not applicable · NCT05022446

The Impact of COVID-19 on Pulmonary Procedures

This study investigates the changes in practice by pulmonary procedural programs across the United States as they faced the coronavirus pandemic. Information gathered from this study may help guide pulmonary programs on a wider scale and improve their practice. The study may also help researchers understand where they should focus research efforts to better respond to a pandemic in the future.

Observational
Terminated · Not applicable · NCT04106973

Mesothelioma Early Detection by VOCs

This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile.

MesotheliomaEarly-stage or resectableObservational
Enrolling By Invitation · Not applicable · NCT07517692

Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening

The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are: * Does the patient and provider support increase the number of patients who complete lung cancer screening? * Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening? * Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening. Primary care provider participants will: * Receive the provider support session and educational materials, or follow usual practice * Answer a baseline survey and a follow-up survey in 6 months * Answer additional survey questions regarding the acceptability of the provider support session if they receive it Patient participants will * Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care * Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.

Supportive or behavioral careScreeningInterventional
Completed · Not applicable · NCT05785845

Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer

This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy (CT-STAR) to central and ultra-central early-stage non-small cell lung cancers on grade 3 or greater toxicity. Online adaptive radiation therapy was until recently only done clinically on an integrated MRI-guided system, but recently, Varian Medical Systems has created a CT-guided radiotherapy machine capable of online adaptive radiotherapy (ETHOS). The vast majority of stereotactic body radiotherapy (SBRT) for early-stage lung cancers is performed on a CT-guided machine rather than an MRI-guided machine, necessitating the evaluation of adaptive radiotherapy using ETHOS in this population. Historically, the non-adaptive, stereotactic treatment of central and ultra-central thoracic disease has been associated with unacceptable rates of grade 3+ toxicity. This has resulted in widespread adoption of a hypofractionated, less ablative 8-15 day treatment courses, with a baseline, one-year grade 3+ toxicity rate of 20%. Use of CT-STAR with daily, CT-guided plan adaptation to carefully spare adjacent organs-at-risk (OAR) in this setting may enable safe delivery of a shorter (5 fraction) and more ablative radiotherapy course.

Non-small cell lung cancer (NSCLC)Early-stage or resectableRadiation therapyTreatmentInterventional
Recruiting · Not applicable · NCT04151940

PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer

This study investigates the changes in positron emission tomography (PET)/computed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET/CT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVRecurrent or relapsedImmunotherapyChemotherapy
Enrolling By Invitation · Not applicable · NCT05879211

Goal Concordant Care Learning Laboratory

The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.

Supportive or behavioral careSupportive CareInterventional
Completed · Not applicable · NCT03776253

Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer

This trial will pilot a psychosocial intervention called Conquer Fear Support (CFS) in patients with stage III-IV lung or gynecologic cancer who are experiencing fear of cancer progression. The intervention is adapted from a novel program called "Conquer Fear" which was developed by researchers in Australia. CFS may help in reducing worries, fears, and uncertainty in patients with advanced lung or gynecological cancer.

Locally advancedMetastatic or stage IVSupportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT07408531

LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)

This research study aims to investigate methods for enhancing lung cancer screening. The study will investigate whether an artificial intelligence (AI) tool, known as Sybil, can aid in predicting the risk of lung cancer. The investigators will also examine whether expanding the screening criteria (based on the guidelines of the Potter and American Cancer Society (ACS)) can help identify individuals at risk who are not currently included in the U.S. Preventive Services Task Force (USPSTF) guidelines.

ScreeningInterventional
Recruiting · Not applicable · NCT05995821

Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies

This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are receiving treatments known or thought to have an effect on the immune system. The goal of this discovery and exploratory study is to: * Understand changes in the immune system associated with various cancer treatments, in order to better design new therapies or tests to predict how these treatments might work. * Identify risk factors for those who go on to develop side effects from immunotherapy. * Identify the molecular features associated with response and resistance to cancer therapies and immunotherapy using integrative genomic and immune repertoire characterization. * Capture and characterize systemic tumor burden by minimally invasive analyses of circulating tumor DNA. Participants may be asked to: * Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue samples. * Complete questionnaires about immunotherapy side effects at baseline and with follow-up appointments. * Undergo knee x-rays. * Allow the use of demographic and clinical information.

ImmunotherapyObservational
Active Not Recruiting · Not applicable · NCT05144542

Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer

This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.

Basic ScienceInterventional
Recruiting · Not applicable · NCT07412041

Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study

The purpose of this study is to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.

Non-small cell lung cancer (NSCLC)Early-stage or resectableSupportive or behavioral careSupportive CareInterventional
Active Not Recruiting · Not applicable · NCT06486428

Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies

This study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with SCLC, in the context of a bio-specimen collection study. The study will also assess self-reported preferences and needs of patients with SCLC, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.

Small cell lung cancer (SCLC)Observational
Withdrawn · Not applicable · NCT07075627

A Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)

This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. Screening and/or medical record review for symptoms associated with Lambert Eaton Myasthenic Syndrome (LEMS) will be conducted.

Small cell lung cancer (SCLC)Observational
Completed · Not applicable · NCT04640259

Epidemiology of Young Lung Cancer - Survey

This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.

Non-small cell lung cancer (NSCLC)Observational
Recruiting · Not applicable · NCT06199570

Support for Cancer Patients Awaiting News

This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and/or protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).

Supportive or behavioral careSupportive CareInterventional
Active Not Recruiting · Not applicable · NCT05715255

Adaptive Symptom Self-Management Immunotherapy Study

The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.

ImmunotherapySupportive or behavioral careSupportive CareInterventional
Recruiting · Not applicable · NCT06410300

Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

Non-small cell lung cancer (NSCLC)Small cell lung cancer (SCLC)ImmunotherapyChemotherapyRadiation therapy
Not Yet Recruiting · Not applicable · NCT07728773

A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)

Patients with lung cancer often experience shortness of breath, also known as dyspnea. It affects over 80% of patients with lung cancer at diagnosis and is linked to poorer quality of life and functioning. Unfortunately, current treatments-such as opioids, which are the most studied treatment for dyspnea-fail to provide patients with adequate care, and dyspnea can remain a chronic issue in many. Even when new treatments are developed, the benefit to public health is often limited by healthcare systems not having enough resources to use new treatments. The investigators' aim is to test a personalized treatment for dyspnea that can address patients' unique needs while efficiently using healthcare resources to make the treatment as accessible as possible for future widespread use. This project builds upon rhe investigators' prior work creating two promising psychological treatments for dyspnea. The first (a two-session behavioral treatment provided by nurses) targets dyspnea-related discomfort. The second (a five-session psychological treatment provided by psychologists) targets dyspnea-related anxiety and overall health outcomes. The investigators combined these complementary treatments with a stepped-care model into a treatment called INSPIRE. In INSPIRE, all patients will receive the brief treatment to learn basic behavioral coping skills to manage the discomfort of dyspnea before escalating to the more intensive treatment that focuses on providing patients with the confidence to cope with dyspnea and related anxiety, but only if patients' dyspnea does not improve after the first treatment. The investigators will first ask for initial feedback from patients who are receiving INSPIRE for dyspnea and the patients' study clinician to make sure the treatment and study procedures fit their needs. The investigators want to see if this approach can work in patients with lung cancer, is well-received, and shows early signs of improving dyspnea. The investigators' goal is to provide personalized relief for breathing difficulties while making the best use of healthcare resources. These findings will help the investigators learn more about how to support patients with dyspnea and provide information on how to further test INSPIRE. Additionally, this personalized supportive treatment for dyspnea may potentially help reduce the use of opioids currently used in the treatment of dyspnea.

Supportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Recruiting · Not applicable · NCT07008664

Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer

The purpose of this research study is to test a new process for diagnosing lung cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.

Observational
Not Yet Recruiting · Not applicable · NCT07723495

Symptom Management to Improve Completion of Patient-reported Outcome Measures

In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and those who do not receive these (control arm). PRO measures are validated tools that capture health-related perspectives directly from the patient and are complementary to provider assessment. Timely completion of PRO assessments and symptoms management of moderate or severe symptoms are essential to improve quality of life and decrease unwanted health care utilization. However, only \~40% of patients complete PRO assessments in clinical settings. In addition, systemic therapy for cancer results in many symptoms (e.g., dry mouth, shortness of breath, constipation) not covered by the disease-general Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Patients in the control arm will receive the existing PROMIS assessments and a thank you message upon completion. Patients in the intervention arm will receive the PROMIS assessments in addition to nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms, and evidence-based self-management strategies Handbook for those with elevated symptoms. Patients in the intervention arm will enter their symptoms in a SMS text and they will be directed to the handbook for strategies to manage their elevated symptoms using a digital platform-Computerized Intervention Authoring System (CIAS)-integrated within the Epic electronic health records. Information gathered has the potential to influence cancer care practices on a larger scale, shaping policies and clinical practices to improve health outcomes for cancer patients and reducing the burden of cancer-related symptoms.

Supportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Active Not Recruiting · Not applicable · NCT02178163

Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid \[DNA\]) and help doctors to tailor treatment to target the specific mutations.

Non-small cell lung cancer (NSCLC)Metastatic or stage IVRecurrent or relapsedInterventional
Active Not Recruiting · Not applicable · NCT05250037

The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)

This observational trial studies whether respiratory viruses are the cause of lung disease (bronchiolitis obliterans syndrome \[BOS\] or graft-versus-host disease of the lung) and changes in lung function in patients who have received a donor stem cell transplant. Patients with chronic graft-versus-host disease (cGVHD) are at higher risk of developing BOS. Studies have also shown that patients who had a respiratory viral illness early after their transplant are at higher risk of developing lung problems later on. Patients who are at risk and who already have BOS might benefit from being monitored more closely. Spirometry is a way of assessing a patient's lung function and is often used to diagnose lung disease. Spirometry measured at home with a simple handheld device may reduce the burden of performing pulmonary function testing at a facility and potentially help patients get their lung disease diagnosed and treated sooner.

Observational
Active Not Recruiting · Not applicable · NCT01696994

Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for ovarian cancer. The ovarian cancer screening tests are part of a trial that addresses the screening of four cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).

ScreeningInterventional
Active Not Recruiting · Not applicable · NCT00002540

Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.

ScreeningInterventional
Active Not Recruiting · Not applicable · NCT01696968

Screening for Lung Cancer in Older Patients (PLCO Screening Trial)

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.

ScreeningInterventional
Active Not Recruiting · Not applicable · NCT01696981

Screening for Colorectal Cancer in Older Patients (PLCO Screening Trial)

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for colorectal cancer.

ScreeningInterventional
Recruiting · Not applicable · NCT07042243

The Florida ASCENT Study

The goal of this clinical trial is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with cancer. The main hypotheses it aims to test are: * At the patient level, the intervention will result in higher levels of food security, self- efficacy for dietary behaviors, and higher diet quality than standard care. * At the provider level, the intervention will be feasible, acceptable, appropriate, and able to enhance individualized care for patient wellness. Researchers will compare cancer patients receiving the MyCarePulse and ASCENT patient navigator intervention to those receiving standard care, to see if the intervention improves food security, self-efficacy, and diet quality. Phase 1 Patient Participants will: * Complete the ASCENT Questionnaire, which is comprised of the following: * U.S. Food Security Survey Module (U.S. FSSM) * Patient-Reported Outcomes Measurement Information System (PROMIS-29) * General Self-Efficacy Scale (GSE) * Complete the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool a total of 4 times. * Be assessed using the Veggie Meter instrument * Participate in two semi-structured interviews Provider Participants will: •Participate in one semi-structured interview Phase 2 Patient Participants will: * Participate in ASCENT patient navigator screenings and consultations * Complete the ASCENT Questionnaire, which comprises the U.S. FSSM, PROMIS-29, and ASA24®

Supportive or behavioral careSupportive CareInterventionalSurvivorship and quality of life
Recruiting · Not applicable · NCT04491292

Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce

This study investigates the impact of the COVID-19 pandemic on the psychosocial health of employees of MD Anderson Cancer Center. Epidemics have been shown to promote psychological stress among medical staff in high risk areas, which may lead to mental health problems. Assessing how the pandemic is affecting employees may allow for more comprehensive actions to be taken to protect the mental health of employees.

Observational
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We use structured ClinicalTrials.gov fields when available and conservative exact-term rules for details such as biomarkers and disease setting. Every study page links to the original record, and only the study team can determine eligibility.

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