Precision-MRD: biomarker-guided targeted treatment for colorectal cancer with minimal residual disease
Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease
This study will see if standard biomarker-directed cancer drugs change ctDNA levels in adults with colorectal cancer who have minimal residual disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06878131 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (over 18) with histologically confirmed colorectal adenocarcinoma, stage II–IV with no definitive radiographic disease, a positive ctDNA test >21 days after surgery or adjuvant therapy, and one of the specified targetable biomarkers are ideal candidates.
Not a fit: Patients without a detectable ctDNA signal, without one of the listed targetable biomarkers, or who are not receiving the specified standard-of-care targeted regimens are unlikely to benefit from this observational protocol.
Why it matters
Potential benefit: If successful, results could help show whether biomarker-directed therapies can clear MRD detectable by ctDNA and thereby guide earlier treatment decisions to reduce recurrence risk.
How similar studies have performed: Prior work has shown ctDNA can predict recurrence and that targeted therapies work in metastatic CRC, but using biomarker-directed therapy specifically to clear MRD is a relatively new approach with limited prospective data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.