cfDNA blood test using 5mC/5hmC to predict response to EGFR or VEGF targeted therapy in metastatic colorectal cancer
Official title: Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Identify Determinants of Response In VEGF/EGFR-targeted Therapy for Metastatic Colorectal Cancer
Run by City of Hope Medical Center · NCT07224841 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | cetuximab, panitumumab, bevacizumab |
| 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 | NCT07224841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
-
ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients
This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.
-
HDM2017 combination therapy in advanced colorectal cancer
A small and mid-size study tests HDM2017 with standard chemotherapy and targeted drugs to see if it’s safe and may help people with unresectable or metastatic colorectal cancer.
-
Retlirafusp alfa with bevacizumab and chemotherapy (with or without short radiotherapy) for colorectal cancer liver metastases
This study tests whether adding retlirafusp alfa to bevacizumab and chemotherapy, with or without short-course radiotherapy, can help patients with advanced colorectal cancer that has spread to the liver.
-
SHR-1701 with short-course radiotherapy and CAPOX before surgery for locally advanced rectal cancer
This will test whether adding the drug SHR-1701 to short-course radiotherapy plus CAPOX before surgery helps people with locally advanced rectal cancer.
-
TGI-5 alone and with nivolumab for advanced or metastatic solid tumors
This trial tests whether TGI-5 by itself or combined with nivolumab is safe and can shrink tumors in adults with advanced or metastatic colorectal cancer, melanoma, hepatocellular carcinoma, or non‑small cell lung cancer who have exhausted standard treatments.
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.