Colorectal Cancer Stage IV, Microsatellite Instability
Conditions
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.
Interventions
PROCEDURESpecimen Collection
Undergo collection of blood samples
PROCEDURESerial Liquid Biopsy
Undergo serial liquid biopsy
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens | Up to 1 year | MSI testing distinguishes between tumors into one of 3 phenotypic categories: MSI-High (MSI-H) is reported when \> 30% of biomarkers show instability; Microsatellite stable (MSS) is reported in the absence of instability. The third category, MSI-Low (MSI-L) is diagnostically equivalent to MSS, and is reported when MSI is present in \< 30% of biomarkers. MSI status will be determined by polymerase chain reaction (PCR) using commercial kits provided by Promega. |
Countries
United States
Outcome results
None listed