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SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation | Clinical Trials | Clareo Health

RECRUITING

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

NCT05935384•Guardant Health, Inc.

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
+4 more criteria

Exclusion Criteria

•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

Locations (1)

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

Key Dates

Start Date

October 25, 2023

Primary Completion Date

December 30, 2030

Completion Date

December 30, 2030

Last Updated

August 22, 2025

Enrollment

470

ESTIMATED participants

Conditions

Non-small Cell Lung CancerColorectal CancerBreast Cancer

Interventions

Guardant360

DIAGNOSTIC_TEST

Contacts

Clinical Trial Operations

CONTACT

8556988887 sibyl@guardanthealth.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Inclusion Criteria

Exclusion Criteria

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