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

Conditions

• CRC (Colorectal Cancer)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jun 21, 2024

Status verified

Nov 2025

Primary completion

Jun 18, 2026

Completion

Jun 18, 2026

Study Design

Enrollment

600 participants (estimated)

Arms

• Arm: Discovery Cohort - PFS ≥ 12 Months (Responder)
  Patients with mCRC who achieved progression-free survival ≥ 12 months after first-line chemotherapy (FOLFOX or FOLFIRI). cfDNA 5mC/5hmC sequencing performed to identify epigenetic determinants of durable response.
• Arm: Discovery Cohort - PFS < 12 Months (Non-Responder)
  Patients with progression-free survival \< 12 months after first-line chemotherapy. Compared with responders to identify epigenetic features associated with resistance.
• Arm: Training Cohort - PFS ≥ 12 Months (Responder)
  Independent mCRC cohort with long PFS (≥12M). Targeted sequencing (EpiCORE assay) to refine predictive markers.
• Arm: Training Cohort - PFS < 12 Months (Non-Responder)
  Independent mCRC cohort with short PFS (\<12M). Targeted sequencing to validate resistance-associated markers.
• Arm: Validation Cohort - PFS ≥ 12 Months (Responder)
  Independent validation cohort analyzed with qPCR-based EpiCORE assay to confirm biomarker predictive accuracy.
• Arm: Validation Cohort - PFS < 12 Months (Non-Responder)
  Independent validation cohort with poor PFS analyzed to assess specificity and model performance.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 36 months from initiation of first-line chemotherapy ]

Central Contacts

• Ajay Goel, PhD
  6263598111
  [email protected]

Locations (1)

Find similar trials in Duarte, CA

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