- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594448
Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients
Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability.
II. To test the hypothesis that changes in the electrophoretic mobility profile of microsatellite biomarkers in liquid biopsies from patients with colorectal carcinoma correlate with therapeutic responsiveness measured based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
III. To determine whether microsatellite alleles generated as a result of microsatellite instability detectable in liquid biopsy specimens from patients with colorectal carcinoma represent the entire cancer cell population or only a subset of cancer cells differentially affected by genomic instability.
OUTLINE:
Participants undergo collection of blood samples to evaluate microsatellite instability via serial liquid biopsies at baseline, then every 6 weeks and at progression or 9 months.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rabia Rehman
- Phone Number: 323-865-0460
- Email: Rabia.Rehman@med.usc.edu
Study Locations
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California
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Los Angeles, California, United States, 90033
- Recruiting
- USC / Norris Comprehensive Cancer Center
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Contact:
- Afsaneh Barzi
- Phone Number: 323-865-3829
- Email: afsaneh.barzi@med.usc.edu
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Principal Investigator:
- Afsaneh Barzi
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Newport Beach, California, United States, 92663
- Recruiting
- USC Norris Oncology/Hematology-Newport Beach
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Contact:
- Kristy Massopust
- Email: Kristy.Massopust@med.usc.edu
-
Principal Investigator:
- Umair Ghani, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy.
- Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy.
- Zubrod performance status of 0 or 1.
- Patients have measurable disease according to RECIST version (v)1.1.
- Ability to understand and willing to sign a written informed consent.
Exclusion Criteria:
- Severe anemia (hemoglobin [Hb] < 8 g/dL).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ancillary-correlative (Specimen collection)
Participants undergo collection of blood samples in addition to the usual amount collected when they come in for their regular cancer treatments or doctor?s appointment every 6-8 weeks until disease progression or stopping at 9 months.
|
Undergo collection of blood samples
Undergo serial liquid biopsy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens
Time Frame: Up to 1 year
|
MSI testing distinguishes between tumors into one of 3 phenotypic categories: MSI-High (MSI-H) is reported when > 30% of biomarkers show instability; Microsatellite stable (MSS) is reported in the absence of instability.
The third category, MSI-Low (MSI-L) is diagnostically equivalent to MSS, and is reported when MSI is present in < 30% of biomarkers.
MSI status will be determined by polymerase chain reaction (PCR) using commercial kits provided by Promega.
|
Up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heinz Josef Lenz, MD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3C-18-2 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2018-01169 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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