SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Guardant Health

Status

Enrolling

Conditions

Breast Cancer

Non-small Cell Lung Cancer

Colorectal Cancer

Treatments

Diagnostic Test: Guardant360

Study type

Observational

Funder types

Industry

Identifiers

NCT05935384

06-MX-001

Details and patient eligibility

About

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.

Enrollment

440 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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