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

NCT06878131 | Recruiting

• 1 other identifier: 2024-1886
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse events (AEs)

  Through study completion; an average of 1 year.

Interventions

Colorectal Cancer BEHAVIORAL

Participants that take part in this research, will be responsible for following study directions and allowing blood samples to be collected every 3 months for correlative studies.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

You may qualify if:

• Male or female subjects aged \> 18 years.
• Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
• Stage II-IV disease per current AJCC staging criteria with no definitive radiographic evidence of disease following locoregional treatment. Small indeterminate lesions measuring \< 10 mm may be permitted at the discretion of the principal investigator.
• Presence of one of the following targetable biomarkers on tumor or blood molecular testing: BRAF V600E mutation (Cohort A), KRAS G12C mutation (Cohort B), MSI-H status (Cohort C), and HER2 amplification (Cohort D).
• Positive ctDNA blood test obtained \> 21 days after surgery or last administration of adjuvant therapy.
• Prescribed one of the following standard-of-care targeted therapy regimens: BRAF V600E Inhibitor + anti-EGFR antibody for BRAF V600E-mutated tumors, KRAS G12C Inhibitor + anti-EGFR antibody for KRAS G12C-mutated tumors, anti-PD-1 antibody +/- anti-CTLA-4 antibody for MMRd/MSI-H tumors, or anti-HER2 therapies for HER2 amplified tumors.

You may not qualify if:

• Prior exposure to the following classes of biomarker-directed therapies: BRAF V600E inhibitors, anti-EGFR antibodies, KRAS G12C inhibitors, anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 therapies
• Presence of a concurrent malignancy requiring active treatment
• Inability to provide informed consent
• Children will not be enrolled in this study
• Pregnant women will not be enrolled in this study
• Cognitively Impaired subjects will not be enrolled in this study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Saurav Haldar, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saurav Haldar, MD

CONTACT

713-792-2828; GIClinicalTrials@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)