NCT05935384

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 470 (estimated)
• Sponsor: Guardant Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• Colorectal Cancer
• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-25
• Primary completion: 2030-12-30
• Completion: 2030-12-30
• First posted: 2023-07-07
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States