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

Recruiting now

Conditions studied: CRC (Colorectal Cancer)

In brief

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.

Key facts

Study ID

NCT07224815

Run by

City of Hope Medical Center

People needed

600

Starts

2024-06-21

Expected to finish

2028-06-18

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Medical Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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