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Observational Study of Guardant360 for Cancer Treatment Response

This study, called SIBYL, is looking at how well a test called Guardant360 can measure your body's response to cancer treatments. Guardant360 is a blood test that looks for tiny pieces of cancer DNA (circulating tumor DNA or ctDNA) in your blood. The study aims to see if changes in these ctDNA levels can show how well your treatment is working, compared to standard methods like CT scans. You might be able to join if you are at least 18 years old, have non-small cell lung cancer, colorectal cancer, or breast cancer, and are receiving or about to start systemic therapy (like chemotherapy or targeted therapy). The study will follow participants for up to 6 years to see how well Guardant360 can detect when the cancer progresses. The study plans to enroll 470 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will collect information about your treatment and health over time. It is not a study where you receive a new treatment, but rather a study of a diagnostic test.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 years to measure the sensitivity of ctDNA to detect disease progression.

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NCT05935384

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Recruiting
Not specifiedAges 18+Observational
Guardant Health, Inc.
~470 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:Guardant360

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of ctDNA to Detect Disease Progression
Measured over 6 years

Conditions

Non-small Cell Lung Cancer
Colorectal Cancer
Breast Cancer

Explore related trials

Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Clinical Trial Operations
[email protected]
8556988887
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Sensitivity of ctDNA to Detect Disease Progression6 years

    The Primary Endpoint, sensitivity of ctDNA to detect disease progression, will be evaluated from all eligible subjects within the primary study cohorts (breast cancer, NSCLC, or CRC)