Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    35
  • sponsor
    University of Southern California
Updated on 3 March 2022

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.

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.

Details
Condition Microsatellite Instability, Colorectal Cancer Stage IV
Treatment Specimen collection, Serial Liquid Biopsy
Clinical Study IdentifierNCT03594448
SponsorUniversity of Southern California
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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