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

Recruiting now

Conditions studied: CRC (Colorectal Cancer)

In brief

The EpiDRIVE study aims to identify cfDNA-based epigenetic determinants of response in metastatic colorectal cancer (mCRC) patients treated with EGFR- or VEGF-targeted therapy. By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to develop a predictive biomarker panel capable of differentiating responders from non-responders to targeted therapy.

Key facts

Study ID

NCT07224841

Run by

City of Hope Medical Center

People needed

500

Starts

2024-06-21

Expected to finish

2028-06-18

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• City of Hope Medical Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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