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

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 design

Treatments tested in this trial

  • cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)
  • EpiCORE Assay (Targeted Sequencing / qPCR Validation)

Treatment groups

600 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators