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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 11, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Guardant Health, Inc.
- Interventions being studied
- Diagnostic Test: Guardant360
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
- Each participant must satisfy all the following criteria to be enrolled in the study: 1. Age ≥18 years old 2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study 3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy 4. Able to understand, and capable of providing written consent to participate in the study 5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent 6. Are willing to provide blood samples at enrollment and at subsequent clinical visits 7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:
- Cohort 1: Unresectable Stage III/IV NSCLC (\~125)
- Cohort 2: Stage IV Colorectal (\~125)
- Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55)
- Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55)
- Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55)
- Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.
Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study: 1. History of prior solid malignancy or hematological malignancy within five years of enrollment 2. Life expectancy ≤12 weeks 3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen 4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Orchard Healthcare Research Inc.Skokie, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 11, 2026. Always confirm current availability with the study team.