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Search / Trial NCT06878131

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

Launched by M.D. ANDERSON CANCER CENTER · Mar 10, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • 1. Male or female subjects aged \> 18 years.
  • 2. Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
  • 3. 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.
  • 4. 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).
  • 5. Positive ctDNA blood test obtained \> 21 days after surgery or last administration of adjuvant therapy.
  • 6. 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.
  • Exclusion Criteria
  • 1. 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
  • 2. Presence of a concurrent malignancy requiring active treatment
  • 3. Inability to provide informed consent
  • 4. Children will not be enrolled in this study
  • 5. Pregnant women will not be enrolled in this study
  • 6. Cognitively Impaired subjects will not be enrolled in this study

Trial Officials

Saurav Haldar, MD

Principal Investigator

M.D. Anderson Cancer Center

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported