CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 600 target
Drug / intervention
cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07224815
NCT07224815N/ARecruitingOn TrackUpdated 7mo ago
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Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer

City of Hope Medical Center·observational·Posted Nov 5, 2025·Updated Nov 5, 2025

In Brief

An observational study evaluating cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase) and EpiCORE Assay (Targeted Sequencing / qPCR Validation) for CRC (Colorectal Cancer). Currently recruiting, targeting 600 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCRC (Colorectal Cancer)
CountriesUnited States
Collaborators--

Timeline

N/ARecruitingOverdue
20252026
First PostedNov 5, 2025
Enrollment StartJun 21, 2024
Primary CompletionJun 18, 2026
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 8 months ago

Interventions

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

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

EpiCORE Assay (Targeted Sequencing / qPCR Validation)other

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.