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cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer
Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma (mCRC). * Received first-line chemotherapy (FOLFOX or FOLFIRI). * Availability of pre-treatment serum or plasma samples for cfDNA 5mC/5hmC analysis. * Documented radiologic or clinical response evaluation (RECIST 1.1 or PFS-based). * RAS/BRAF mutation status available. Exclusion Criteria: * Inadequate cfDNA yield or poor DNA quality. * Non-adenocarcinoma histology. * Active inflammatory or autoimmune disease that may alter cfDNA methylation. * Concomitant malignancy requiring systemic therapy.
About the study
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.
What is being tested
- cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase) (diagnostic test)
- EpiCORE Assay (Targeted Sequencing / qPCR Validation) (diagnostic test)
Sponsor: City of Hope Medical Center · Participants: 600 · Started: Jun 21, 2024
Contact the study team
- Ajay Goel, PhD · Phone: 6263598111
Official record on ClinicalTrials.gov — NCT07224815
Locations in the U.S.
| California | City of Hope Medical Center, Duarte |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.