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NCT07224854Active, not recruiting

Epigenetic Signature for CRC Early Detection

A Model of Epigenetic Biomarkers Based on cfDNA 5mC/5hmC for Early Detection of Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
3 Nov 2025
Start date
21 Jun 2024
Primary completion date
18 Jun 2028
Lead sponsor
City of Hope Medical Center
NCT number
NCT07224854

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 21 Jun 2024 to the primary completion date, 18 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent malignancies outside the gastrointestinal tract (unless in complete remission ≥5 years).
  • Recent chemotherapy, radiotherapy, or major surgery within 4 weeks prior to blood collection (if prospective samples).

Other illness

  • Any condition precluding reliable sample analysis or participation.

Other

  • Samples with insufficient volume or poor cfDNA quality.

Who the study is looking for

  • Adults aged ≥18 years at the time of sample collection.
  • Patients with confirmed CRC or non-cancer controls.
  • Availability of retrospective blood samples collected according to institutional protocols.
  • Willingness to allow use of de-identified clinical and demographic data.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Nat Medical Ctr
Coordinator of this site? Confirm its status
MonroviaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.