Observational Study on cfDNA Biomarkers for Targeted Therapy in mCRC

This observational study, called EpiDRIVE, is looking at how well targeted therapies like cetuximab, panitumumab, and bevacizumab work for people with metastatic colorectal cancer (mCRC). Researchers are studying your blood samples taken before treatment to find special markers in your cell-free DNA (cfDNA) that might predict if these treatments will be effective for you. They are looking at specific changes in your DNA called 5mC and 5hmC. The goal is to develop a test that can help doctors choose the best treatment for you. To join, you need to have mCRC, have received one of these targeted therapies, and have a pre-treatment blood sample available. The study will track how long you live without your cancer getting worse (Progression-Free Survival) for up to 36 months.

Study design
This is an observational study planning to include 500 participants with metastatic colorectal cancer. It is not a treatment study, but rather looks at existing data and samples.
What's involved
You would need to have a pre-treatment plasma sample available for cfDNA analysis. The study will also use your documented radiologic response evaluations.
Compensation
Not stated in the trial record.
Follow-up
Your Progression-Free Survival will be measured for up to 36 months from when your therapy started.

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NCT07224841

Development of a cfDNA 5mC/5hmC-based Biomarker Panel to Predict Targeted Therapy Efficacy in mCRC

Recruiting
Not specifiedAges 18+Observational
City of Hope Medical Center
~500 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:cfDNA 5mC/5hmC Sequencing (EpiDRIVE Discovery Phase)EpiDRIVE Assay (Targeted Sequencing / qPCR Validation)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) according to cfDNA 5mC/5hmC biomarker profile
Measured over Up to 36 months from therapy initiation
CRC (Colorectal Cancer)
1 sites across 1 states
California1
  • Ajay Goel, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Progression-Free Survival (PFS) according to cfDNA 5mC/5hmC biomarker profileUp to 36 months from therapy initiation

    Progression-free survival (PFS) among patients with metastatic colorectal cancer (mCRC) receiving EGFR- or VEGF-targeted therapy, stratified by cfDNA 5mC/5hmC-based biomarker status.