ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Study summary

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedGuardant Reveal

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?57 U.S. locations

Locations may change over time.

Who runs it?Guardant Health, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Guardant Health, Inc.
Interventions being studied: Diagnostic Test: Guardant Reveal

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Age \> 18 years old AND
Initial treatment is given with curative/radical intent AND
Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND
Provided written informed consent to participate in the study AND
Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND
Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 3 years as outlined in the study protocol and informed consent AND
Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen
Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as: Primary Study Cohorts
Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III): Cohort 2A: Resectable OR Cohort 2B: Unresectable,
Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following: Cohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive/HER2-negative invasive breast carcinoma,
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),
Cohort 6: Gastric adenocarcinoma (stage II-III),
Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,
Cohort 8: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus),
Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),
Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),
Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)
Cohort 12: Colorectal adenocarcinoma Cohort 12A: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy-or immunotherapy- containing regimen OR Cohort 12B: Colon adenocarcinoma (stage II-III)

Reasons someone may not be able to joinExclusion criteria

History of allogeneic organ or tissue transplant
Index cancer has predominantly neuroendocrine histology
History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), and stage I papillary thyroid carcinoma, and participants with bilateral/multifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment
Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at BirminghamBirmingham, Alabama
Ironwood Cancer & Research CentersChandler, Arizona
Genesis Cancer CenterHot Springs, Arkansas
University of California, San DiegoLa Jolla, California
Hoag Memorial Hospital PresbyterianNewport Beach, California
Redwood CityRedwood City, California
Sutter Institute for Medical ResearchSacramento, California
University of ColoradoAurora, Colorado
Memorial Healthcare SystemHollywood, Florida
The Oncology Institute of Hope & InnovationLakeland, Florida
Tulane Cancer CenterNew Orleans, Louisiana
Christus Highland/ BoniolShreveport, Louisiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 14, 2026. Always confirm current availability with the study team.

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