- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935384
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
November 17, 2023 updated by: Guardant Health, Inc.
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
440
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trial Operations
- Phone Number: 8556988887
- Email: sibyl@guardanthealth.com
Study Locations
-
-
Illinois
-
Skokie, Illinois, United States, 60077-1384
- Recruiting
- Orchard Healthcare Research Inc.
-
Contact:
- Ira Oliff
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort 1: Unresectable Stage III/IV NSCLC
Blood samples collected will be banked
|
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.
|
Cohort 2: Stage IV Colorectal
Blood samples collected will be banked
|
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.
|
Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-
Blood samples collected will be banked
|
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.
|
Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+
Blood samples collected will be banked
|
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.
|
Cohort 5: Unresectable Stage III/IV Breast - Triple Positive
Blood samples collected will be banked
|
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.
|
Cohort 6: Unresectable Stage III/IV Breast - Triple Negative
Blood samples collected will be banked
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of ctDNA to Detect Disease Progression
Time Frame: 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)
|
6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RECIST Response
Time Frame: 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
|
6 years
|
Progression-Free Survival (PFS)
Time Frame: 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
|
6 years
|
Lead Time
Time Frame: 6 years
|
Lead time: defined as the interval between ctDNA detection or increase and clinical detection of disease progression
|
6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2023
Primary Completion (Estimated)
August 30, 2029
Study Completion (Estimated)
August 30, 2029
Study Registration Dates
First Submitted
June 29, 2023
First Submitted That Met QC Criteria
June 29, 2023
First Posted (Actual)
July 7, 2023
Study Record Updates
Last Update Posted (Actual)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
Other Study ID Numbers
- 06-MX-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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