Actively Recruiting
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Led by Guardant Health, Inc. · Updated on 2025-08-22
470
Participants Needed
1
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Receiving systemic therapy and/or oral standard of care regimen at enrollment site during entire study
- Either treatment naive before first line standard therapy OR completed first line and starting second line standard therapy
- Able to understand and provide written consent
- Willing to share de-identified clinical data with investigators as outlined
- Willing to provide blood samples at enrollment and subsequent clinical visits
- Histologically confirmed unresectable Index cancer qualifying as:
- Cohort 1: Unresectable Stage III/IV Non-small Cell Lung Cancer
- Cohort 2: Stage IV Colorectal Cancer
- Cohort 3: Unresectable Stage III/IV Breast Cancer - HR+ HER2-
- Cohort 4: Unresectable Stage III/IV Breast Cancer - HR- HER2+
- Cohort 5: Unresectable Stage III/IV Breast Cancer - HR+ HER2+
- Cohort 6: Unresectable Stage III/IV Breast Cancer - Triple Negative
You will not qualify if you...
- History of solid or hematological malignancy within last 5 years
- Life expectancy 12 weeks or less
- Unable to provide baseline blood sample before starting standard therapy
- Currently participating in another clinical trial or observational study evaluating genomic tests for response or progression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077-1384
Actively Recruiting
Research Team
C
Clinical Trial Operations
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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