Blood test measuring cfDNA methylation to predict chemotherapy response in metastatic colorectal cancer
Official title: Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer
Run by City of Hope Medical Center · NCT07224815 · Data updated 2026-11-12
This project will test whether a blood test that measures cfDNA 5mC/5hmC patterns can predict which people with metastatic colorectal cancer will respond to first-line FOLFOX or FOLFIRI chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | June 21, 2024 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07224815 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with histologically confirmed metastatic colorectal adenocarcinoma who received first-line FOLFOX or FOLFIRI, have available pre-treatment plasma or serum for cfDNA analysis, and have documented RAS/BRAF status and treatment response data.
✕Probably not a fit
Patients without adequate pre-treatment cfDNA samples, with non-adenocarcinoma histology, active inflammatory/autoimmune conditions that may alter cfDNA methylation, or concurrent malignancies requiring systemic therapy are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The EpiCORE program uses genome-wide profiling of 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) in circulating cell-free DNA to identify epigenetic signatures linked to response to first-line FOLFOX or FOLFIRI in metastatic colorectal cancer. In a discovery phase, researchers will sequence cfDNA 5mC/5hmC across the genome from pre-treatment plasma to find candidate regions associated with response. A training phase will apply targeted sequencing and modeling to refine predictive loci, followed by a validation phase using qPCR-based assays to confirm the finalized EpiCORE panel. Clinical response will be correlated with RECIST 1.1 or progression-free survival measures along with RAS/BRAF status to establish predictive performance.
Why it matters
Potential benefit: If successful, the test could let doctors select the most effective first-line chemotherapy sooner and spare patients from ineffective treatments.
How similar studies have gone: Early research on cfDNA methylation and hydroxymethylation has shown promise for tumor detection and monitoring, but this specific approach to predict chemotherapy response in metastatic colorectal cancer still requires validation in larger cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma (mCRC). * Received first-line chemotherapy (FOLFOX or FOLFIRI). * Availability of pre-treatment serum or plasma samples for cfDNA 5mC/5hmC analysis. * Documented radiologic or clinical response evaluation (RECIST 1.1 or PFS-based). * RAS/BRAF mutation status available. Exclusion Criteria: * Inadequate cfDNA yield or poor DNA quality. * Non-adenocarcinoma histology. * Active inflammatory or autoimmune disease that may alter cfDNA methylation. * Concomitant malignancy requiring systemic therapy.
Where it's running
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City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: ajgoel@coh.org
- Phone: 6263598111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.