Breast Cancer, Colorectal Cancer, Non-small Cell Lung Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTGuardant360
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.
Sponsors
Guardant Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant must satisfy all the following criteria to be enrolled in the study: 1. Age ≥18 years old 2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study 3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy 4. Able to understand, and capable of providing written consent to participate in the study 5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent 6. Are willing to provide blood samples at enrollment and at subsequent clinical visits 7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as: * Cohort 1: Unresectable Stage III/IV NSCLC (\~125) * Cohort 2: Stage IV Colorectal (\~125) * Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55) * Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55) * Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55) * Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.
Exclusion criteria
Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study: 1. History of prior solid malignancy or hematological malignancy within five years of enrollment 2. Life expectancy ≤12 weeks 3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen 4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Lead Time | 6 years | Lead time: defined as the interval between ctDNA detection or increase and clinical detection of disease progression |
Countries
United States
Contacts
CONTACTClinical Trial Operations
Outcome results
None listed