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cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer
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
View on ClinicalTrials.gov →
NCT07224815
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
CRC (Colorectal Cancer)Cancer
Locations1 site
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Actively Recruiting
SponsorCity of Hope Medical Center
Started2024-06-21
Est. completion2026-06-18
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07224815