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RECRUITING
NCT07224815

cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

The EpiCORE study aims to identify cfDNA-based epigenetic markers predictive of response to first-line chemotherapy (FOLFOX or FOLFIRI) in metastatic colorectal cancer (mCRC). By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to establish a non-invasive biomarker panel capable of distinguishing responders from non-responders.

Official title: Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-06-21

Completion Date

2026-06-18

Last Updated

2025-11-05

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)

Genome-wide profiling of cfDNA methylation and hydroxymethylation from pre-treatment plasma to identify molecular determinants associated with chemotherapy efficacy (PFS ≥ 12M vs \< 12M).

DIAGNOSTIC_TEST

EpiCORE Assay (Targeted Sequencing / qPCR Validation)

Targeted validation of cfDNA 5mC/5hmC markers from discovery phase using sequencing and qPCR to build and validate a predictive model for first-line chemotherapy response.

Locations (1)

City of Hope Medical Center

Duarte, California, United States