SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Trial Title: SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

NCT ID: NCT05935384

Condition: Non-small Cell Lung Cancer
Colorectal Cancer
Breast Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Guardant360
Description: 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.
Arm group label: Cohort 1: Unresectable Stage III/IV NSCLC
Arm group label: Cohort 2: Stage IV Colorectal
Arm group label: Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-
Arm group label: Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+
Arm group label: Cohort 5: Unresectable Stage III/IV Breast - Triple Positive
Arm group label: Cohort 6: Unresectable Stage III/IV Breast - Triple Negative

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.

Criteria for eligibility:

Study pop:
The primary study population will include participants with Non-small cell lung cancer (stage III-IV), Colorectal adenocarcinoma (stage III-IV), and Breast Cancer (stage III-IV), as per inclusion/exclusion criteria. Approximately 440 total patients will be enrolled into the study.

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Orchard Healthcare Research Inc.

Address:
City: Skokie
Zip: 60077-1384
Country: United States

Status: Recruiting

Contact:
Last name: Ira Oliff

Start date: October 25, 2023

Completion date: August 30, 2029

Lead sponsor:
Agency: Guardant Health, Inc.
Agency class: Industry

Source: Guardant Health, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05935384