Precision-MRD: biomarker-guided targeted treatment for colorectal cancer with minimal residual disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study that follows colorectal cancer patients who have minimal residual disease (MRD) and a positive ctDNA test after surgery or adjuvant therapy. Participants are grouped by targetable biomarkers (BRAF V600E, KRAS G12C, MSI‑H, or HER2 amplification) and receive biomarker-directed systemic therapy as prescribed by their treating oncologist per standard of care. Blood will be collected to measure ctDNA mutant allele fractions over time, with the primary endpoint being ctDNA clearance at 6 months and secondary endpoints including ctDNA dynamics and one-year recurrence rate. The study is conducted at MD Anderson Cancer Center and does not alter the treating physician's chosen therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Saurav Haldar, MD — M.D. Anderson Cancer Center
• Study coordinator: Saurav Haldar, MD
• Email: GIClinicalTrials@mdanderson.org
• Phone: 713-792-2828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.