SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Breast Cancer Clinical Trial

Official title:

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935384
• Other study ID #: 06-MX-001
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: August 30, 2029

Study information

• Verified date: November 2023
• Source: Guardant Health, Inc.
• Contact: Clinical Trial Operations
• Phone: 8556988887
• Email: sibyl[@]guardanthealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: August 30, 2029
• Est. primary completion date: August 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Will be treated with a first- or second-line systemic and/or oral standard of care regimen at the enrolling site
• Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed a prior line of SOC therapy and will commence subsequent line of SOC therapy
• Provide written informed consent to participate in the study
• Diagnosed with an unresectable advanced solid malignancy and have a histologically

confirmed cancer that qualifies for inclusion, defined as:

• Non-small cell lung cancer (stage III-IV)
• Colorectal adenocarcinoma (stage III-IV)
• Breast Cancer (stage III-IV)

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Country	Name	City	State
United States	Orchard Healthcare Research Inc.	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Guardant Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of ctDNA to Detect Disease Progression	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)	6 years
Secondary	RECIST Response	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	6 years
Secondary	Progression-Free Survival (PFS)	PFS: defined as the quantitative changes in ctDNA that correlate or associate with participant's progression free survival on each line of SOC therapy	6 years
Secondary	Lead Time	Lead time: defined as the interval between ctDNA detection or increase and clinical detection of disease progression	6 years