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Observational Study on cfDNA Biomarkers for Colorectal Cancer Chemotherapy Response

This study, called EpiCORE, is looking at how well certain chemotherapy drugs, FOLFOX or FOLFIRI, work for people with metastatic colorectal cancer (cancer that has spread). Researchers are studying changes in your blood (specifically, cell-free DNA or cfDNA) before you start chemotherapy. They are looking for specific patterns (called 5mC and 5hmC) that might predict if the chemotherapy will be effective for you. The goal is to find a way to tell if a treatment will work by looking at these blood markers. You can join if you have metastatic colorectal cancer, have received first-line FOLFOX or FOLFIRI, and have pre-treatment blood samples available. The study aims to see if these markers can predict how long you go without your cancer getting worse (Progression-Free Survival, or PFS). The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include 600 participants.
What's involved
You would need to have pre-treatment blood samples (serum or plasma) available for analysis. Your medical records regarding your chemotherapy response will also be used.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track your Progression-Free Survival (PFS) for up to 36 months from when you started your first-line chemotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224815

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

Recruiting
Not specifiedAges 18+Observational
City of Hope Medical Center
~600 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)EpiCORE Assay (Targeted Sequencing / qPCR Validation)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to 36 months from initiation of first-line chemotherapy

Conditions

CRC (Colorectal Cancer)

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ajay Goel, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Ajay Goel, PhD
[email protected]
6263598111
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-Free Survival (PFS)Up to 36 months from initiation of first-line chemotherapy

    Progression-free survival (PFS) is defined as the time from initiation of first-line chemotherapy (FOLFOX or FOLFIRI) to the date of documented disease progression or death from any cause, whichever occurs first. The primary objective of the EpiCORE study is to evaluate whether cfDNA 5mC/5hmC-based biomarker profiles (EpiCORE panel) are associated with differences in PFS among patients with metastatic colorectal cancer (mCRC).