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

Recruitingn/aAges 18 Years - anyAllCity of Hope Medical Center
NCT07224841 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • cfDNA 5mC/5hmC Sequencing (EpiDRIVE Discovery Phase)
  • EpiDRIVE Assay (Targeted Sequencing / qPCR Validation)
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Where

1 site
City of Hope Medical Center
Duarte, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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