cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer
Recruiting
Observational Study
CRC (Colorectal Cancer)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
600 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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.…
Inclusion Criteria:
* 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 Criteria:
* 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.
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