Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

NCT03594448 | Terminated DMC

• 3 other identifiers: 3C-18-2NCI-2018-01169P30CA014089
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Microsatellite Instability; Colorectal Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: Specimen Collection; Procedure: Serial Liquid Biopsy

Interventions

Specimen Collection PROCEDURE

Undergo collection of blood samples

Ancillary-correlative (Specimen collection)

Serial Liquid Biopsy PROCEDURE

Undergo serial liquid biopsy

Ancillary-correlative (Specimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy will be recruited.

You may qualify if:

• 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.

You may not qualify if:

• Severe anemia (hemoglobin \[Hb\] \< 8 g/dL).

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Microsatellite Instability; Colorectal Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Heinz Josef Lenz, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 20, 2018
• Study Start: September 5, 2018
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

US (2)