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

First listed

Nov 5, 2025

Start date

Jun 21, 2024

Status verified

Jul 2026

Primary completion

Jun 18, 2028

Completion

Jun 18, 2028

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

Related Studies

• BBO-11818 in Adult Subjects With KRAS Mutant Cancer
  PHASE1 · Recruiting · TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Los Angeles, California
• An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.
  PHASE2 · Recruiting · NGM Biopharmaceuticals, Inc · Los Angeles, California
• Development of a cfDNA 5mC/5hmC-based Biomarker Panel to Predict Targeted Therapy Efficacy in mCRC
  Recruiting · City of Hope Medical Center · Duarte, California
• A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
  PHASE3 · Recruiting · Incyte Corporation · Tucson, Arizona