Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

Colorectal Cancer Stage IV Clinical Trial

Official title:

Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594448
• Other study ID #: 3C-18-2
• Secondary ID: NCI-2018-011693C
• Status: Recruiting
• Start date: September 5, 2018
• Est. completion date: September 5, 2025

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: Rabia Rehman
• Phone: 323-865-0460
• Email: Rabia.Rehman[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 5, 2025
• Est. primary completion date: September 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Colorectal Neoplasms
• Microsatellite Instability

Intervention

Procedure:
• Specimen Collection
Undergo collection of blood samples
• Serial Liquid Biopsy
Undergo serial liquid biopsy

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	USC Norris Oncology/Hematology-Newport Beach	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens	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.	Up to 1 year