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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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

500 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators