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

RECRUITINGSponsored by City of Hope Medical Center
Actively Recruiting
SponsorCity of Hope Medical Center
Started2024-06-21
Est. completion2026-06-18
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions2

CRC (Colorectal Cancer)Cancer

Locations1 site

City of Hope Medical Center
Duarte, California, 91010
Ajay Goel, PhD626-218-3452ajgoel@coh.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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