About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)
- EpiCORE Assay (Targeted Sequencing / qPCR Validation)
Treatment groups
6
Treatment groupsSee each treatment group below.