Epigenetic Signature for CRC Early Detection

The epiCED is a noninvasive blood-based assay designed for early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. This study leverages retrospective, multi-center cohorts of CRC patients and non-cancer controls to discover and validate a robust cfDNA methylation signature. Small-scale sequencing and machine learning-based modeling will be applied to identify a minimal panel of methylation markers that can accurately discriminate CRC from non-cancer individuals, including early-stage disease. The ultimate goal is to develop a clinically practical, noninvasive screening tool that enables population-level early detection and improves patient outcomes.

NCT Number	NCT07224854
Lead Sponsor	City of Hope Medical Center
Conditions	Colorectal Cancer (Diagnosis), Non-cancer Controls, DNA Methylation, Cell Free DNA, Early Detection of Cancer
Enrollment	500 participants
Start Date	2024-06-21
Primary Completion	2028-06-18 (estimated)
Study Completion	2028-06-18 (estimated)
Updated on ClinicalTrials.gov	2026-07-07