Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease

Not yet recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT06878131
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is to learn about the effects of biomarkertargeted therapy on ctDNA in patrticipants with CRC and MRD.

This is an observational study. Participants will be monitored while receiving biomarker-directed therapy that is determined by your treating oncologist (cancer doctor) per standard of care, independent of this study.

Detailed Description

Primary Objective

• To estimate the rate of ctDNA clearance at 6 months following initiation of biomarker-directed targeted therapy in colorectal cancer (CRC) participants with minimal residual disease (MRD).

Secondary Objectives

* To evaluate dynamics of ctDNA mutant allele fractions following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.

* To estimate the rate of disease recurrence at 1 year following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Study Start: 2025-09-30
• Primary Completion: 2026-12-22
• Study Completion: 2028-12-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Adverse events (AEs)	Through study completion; an average of 1 year.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States