Official Title
Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma
Brief Title
Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients
Protocol ID
NCT03594448
Lead Sponsor
University of Southern California
Brief 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.
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 Period
-
Enrollment Count
6 participants
Eligibility Criteria
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).
Filters
Microsatellite Instability
Colorectal Cancer Stage IV
TERMINATED
ADULT
OLDER_ADULT