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

ConditionCRC (Colorectal Cancer)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Patients diagnosed with Stage IV colorectal adenocarcinoma who received first-line FOLFOX or FOLFIRI chemotherapy and have available pre-treatment serum or plasma samples for cfDNA analysis.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)

    Diagnostic test

    Genome-wide profiling of cfDNA methylation and hydroxymethylation from pre-treatment plasma to identify molecular determinants associated with chemotherapy efficacy (PFS ≥ 12M vs \< 12M).

  • EpiCORE Assay (Targeted Sequencing / qPCR Validation)

    Diagnostic test

    Targeted validation of cfDNA 5mC/5hmC markers from discovery phase using sequencing and qPCR to build and validate a predictive model for first-line chemotherapy response.

Treatment groups

600 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Discovery Cohort - PFS ≥ 12 Months (Responder)1 intervention
Group B: Discovery Cohort - PFS < 12 Months (Non-Responder)1 intervention
Group C: Training Cohort - PFS ≥ 12 Months (Responder)1 intervention
Group D: Training Cohort - PFS < 12 Months (Non-Responder)1 intervention
Group E: Validation Cohort - PFS ≥ 12 Months (Responder)1 intervention
Group F: Validation Cohort - PFS < 12 Months (Non-Responder)1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

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).

Time frame
Up to 36 months from initiation of first-line chemotherapy

Secondary outcomes

1

Overall Survival (OS):

Time from chemotherapy initiation to death from any cause

Time frame
Up to 60 months from initiation of first-line chemotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

Source ClinicalTrials.gov
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