Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:September 5, 2018
End Date:September 5, 2021
Contact:Dana Agafitei
Email:Raluca.Agafitei@med.usc.edu
Phone:323-865-0467

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Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma

This pilot trial studies how well serial liquid biopsies work in detecting microsatellite
instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help
doctors learn better methods to track cancer in the bloodstream and how to use these to
improve cancer treatments.

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.

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).
We found this trial at
2
sites
Newport Beach, California 92663
Principal Investigator: Diana L. Hanna
Phone: 949-764-6130
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Afsaneh Barzi
Phone: 323-865-3829
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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