Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-05

Study Completion Date

2023-09-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Microsatellite Instability Colorectal Cancer Stage IV

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Specimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Serial Liquid Biopsy

Intervention Type PROCEDURE

Undergo serial liquid biopsy

Interventions

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Specimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Serial Liquid Biopsy

Undergo serial liquid biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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.