SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
1 other identifier
observational
470
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
August 22, 2025
August 1, 2025
7.2 years
June 29, 2023
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
RECIST Response
6 years
Progression-Free Survival (PFS)
6 years
Lead Time
6 years
Study Arms (6)
Cohort 1: Unresectable Stage III/IV NSCLC
Blood samples collected will be banked
Cohort 2: Stage IV Colorectal
Blood samples collected will be banked
Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-
Blood samples collected will be banked
Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+
Blood samples collected will be banked
Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+
Blood samples collected will be banked
Cohort 6: Unresectable Stage III/IV Breast - Triple Negative
Blood samples collected will be banked
Interventions
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.
Eligibility Criteria
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 470 total patients will be enrolled into the study.
You may qualify if:
- Each participant must satisfy all the following criteria to be enrolled in the study:
- Age ≥18 years old
- Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
- 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
- Able to understand, and capable of providing written consent to participate in the study
- Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
- Are willing to provide blood samples at enrollment and at subsequent clinical visits
- 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.
You may not qualify if:
- Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:
- History of prior solid malignancy or hematological malignancy within five years of enrollment
- Life expectancy ≤12 weeks
- Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077-1384, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 7, 2023
Study Start
October 25, 2023
Primary Completion (Estimated)
December 30, 2030
Study Completion (Estimated)
December 30, 2030
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share