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

About this study

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.

Condition
CRC (Colorectal Cancer)
Tested
cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase), EpiCORE Assay (Targeted Sequencing / qPCR Validation)
Sponsor
City of Hope Medical Center

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Study condition: CRC (Colorectal Cancer)
  • 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 4

  • 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.

Where

1 site, 1 recruiting

City of Hope Medical Center

Duarte, California, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.