SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Recruiting

• Conditions: Non-small Cell Lung Cancer; Colorectal Cancer; Breast Cancer
• Interventions: Diagnostic Test: Guardant360

• Registration Number: NCT05935384
• Lead Sponsor: Guardant Health, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-07
• Study Start: 2023-10-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18
• Primary Completion: 2029-08-30
• Study Completion: 2029-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

• History of a prior solid or hematological malignancy within 5 years of enrollment
• Life expectancy < 12 weeks
• Unable to collect baseline blood sample prior to starting SOC regimen
• Is participating in an interventional clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2: Stage IV Colorectal	Guardant360	Blood samples collected will be banked
Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-	Guardant360	Blood samples collected will be banked
Cohort 6: Unresectable Stage III/IV Breast - Triple Negative	Guardant360	Blood samples collected will be banked
Cohort 5: Unresectable Stage III/IV Breast - Triple Positive	Guardant360	Blood samples collected will be banked
Cohort 1: Unresectable Stage III/IV NSCLC	Guardant360	Blood samples collected will be banked
Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+	Guardant360	Blood samples collected will be banked

Primary Outcome Measures

Name	Time	Method
Sensitivity of ctDNA to Detect Disease Progression	6 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)

Secondary Outcome Measures

Name	Time	Method
Lead Time	6 years	Lead time: defined as the interval between ctDNA detection or increase and clinical detection of disease progression
RECIST Response	6 years	RECIST v1.1 response: defined as the tumor response to treatment as measured by restaging scans in subjects who have increasing or decreasing ctDNA quantities before the time of scan and correlating this change with the clinical response
Progression-Free Survival (PFS)	6 years	PFS: defined as the quantitative changes in ctDNA that correlate or associate with participant's progression free survival on each line of SOC therapy

Trial Locations

Locations (1)

Orchard Healthcare Research Inc.; 🇺🇸 Skokie, Illinois, United States