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RECRUITING
NCT05935384

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Sponsor: Guardant Health, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

470

Start Date

2023-10-25

Completion Date

2030-12-30

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Guardant360

Guardant360 is a qualitative next generation sequencing (NGS)-based in vitro diagnostic device for detection of single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions in genes frequently mutated in cancer, using circulating cell-free DNA (cfDNA) obtained from the plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes.

Locations (1)

Orchard Healthcare Research Inc.

Skokie, Illinois, United States