About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- cfDNA 5mC/5hmC Sequencing (EpiDRIVE Discovery Phase)
- EpiDRIVE Assay (Targeted Sequencing / qPCR Validation)
Treatment groups
6
Treatment groupsSee each treatment group below.