Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

Last updated: August 27, 2024
Sponsor: University of Southern California
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

Serial Liquid Biopsy

Specimen Collection

Clinical Study ID

NCT03594448
3C-18-2
NCI-2018-01169
3C-18-2
P30CA014089
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients newly diagnosed with stage IV colorectal cancer and with definedmicrosatellite instability status before initiation of systemic immunotherapy.

  • Trackable cancer-driver mutation in the primary tumor documented before initiationof 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

Exclusion Criteria:

  • Severe anemia (hemoglobin [Hb] < 8 g/dL).

Study Design

Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Serial Liquid Biopsy
Phase:
Study Start date:
September 05, 2018
Estimated Completion Date:
September 18, 2023

Study 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.

Connect with a study center

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Hoag Memorial Hospital

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California 92663
    United States

    Site Not Available

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