NCT07224815Recruiting
cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer
Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 3 Nov 2025
- Start date
- Jun 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT07224815
What you commit to
- Study type: Observational
- Planned participants: 600
- From Jun 2024 to the primary completion date, 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
- Concomitant malignancy requiring systemic therapy.
Other illness
- Active inflammatory or autoimmune disease that may alter cfDNA methylation.
Other
- Inadequate cfDNA yield or poor DNA quality.
- Non-adenocarcinoma histology.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.