MedTrace Logo

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

NCT07224815 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • CRC (Colorectal Cancer)

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.

Sponsors & Collaborators

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ajay Goel, PhD · City of Hope Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2028-06-18
Completion
2028-06-18

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224815 on ClinicalTrials.gov