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

RECRUITINGSponsored by City of Hope Medical Center
Actively Recruiting
SponsorCity of Hope Medical Center
Started2024-06-21
Est. completion2026-06-18
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CRC (Colorectal Cancer)Cancer

Locations1 site

City of Hope Medical Center
Duarte, California, 91016
Ajay Goel, PhD626-218-3452ajgoel@coh.org

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