cfDNA blood test using 5mC/5hmC to predict response to EGFR or VEGF targeted therapy in metastatic colorectal cancer
Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Identify Determinants of Response In VEGF/EGFR-targeted Therapy for Metastatic Colorectal Cancer
This project will test if a blood test that measures cfDNA methylation (5mC/5hmC) can tell which people with metastatic colorectal cancer are likely to respond to EGFR- or VEGF-targeted treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | cetuximab, panitumumab, bevacizumab |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07224841 on ClinicalTrials.gov |
What this trial studies
The study collects pre-treatment plasma from patients with metastatic colorectal adenocarcinoma who received EGFR- or VEGF-targeted therapy and performs whole-genome 5mC/5hmC profiling to find differences between responders and non-responders. A targeted sequencing training phase will be used to build an EpiDRIVE cfDNA epigenetic panel, followed by qPCR-based validation of selected markers in an independent cohort. Clinical response is defined by documented radiologic evaluation (RECIST 1.1) and known RAS/BRAF status will be incorporated into analyses. The approach aims to produce a non-invasive biomarker panel that could complement existing molecular markers for therapy selection.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed metastatic colorectal adenocarcinoma who received EGFR- or VEGF-targeted therapy, have a pre-treatment plasma sample available, and have known RAS/BRAF mutation status.
Not a fit: Patients without adequate cfDNA quantity/quality, with non-adenocarcinoma histology, concurrent active other malignancies, or active inflammatory/autoimmune conditions that alter cfDNA methylation profiles may not benefit from this approach.
Why it matters
Potential benefit: If successful, this could provide a simple blood test to help choose the most effective targeted drug and avoid ineffective treatments for people with metastatic colorectal cancer.
How similar studies have performed: Early research supports cfDNA methylation as a promising non-invasive marker, but combined 5mC/5hmC panels specifically for predicting targeted therapy response in mCRC remain exploratory and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma (mCRC). * Received EGFR-targeted therapy (cetuximab/panitumumab) or VEGF-targeted therapy (bevacizumab). * Availability of pre-treatment plasma sample for cfDNA analysis. * Documented radiologic response evaluation (RECIST 1.1). * RAS/BRAF mutation status known. Exclusion Criteria: * Inadequate cfDNA quality or low cfDNA yield. * Non-adenocarcinoma histology. * Concurrent or prior other active malignancy. * Active inflammatory or autoimmune disease affecting cfDNA methylation profiles.
Where this trial is running
Duarte, California
- 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: 626-359-8111
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.