RecruitingNCT07224815

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

Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer


Sponsor

City of Hope Medical Center

Enrollment

600 participants

Start Date

Jun 21, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing stored blood samples from people with metastatic colorectal cancer (colorectal cancer that has spread) to see whether specific chemical modifications on tumor DNA released into the bloodstream (called 5mC and 5hmC markers) can predict how well a patient will respond to standard chemotherapy regimens like FOLFOX or FOLFIRI. **You may be eligible if...** - You have been confirmed to have metastatic colorectal adenocarcinoma - You received first-line chemotherapy with FOLFOX or FOLFIRI - Blood (serum or plasma) samples collected before treatment started are available - Your tumor's RAS and BRAF mutation status is documented - Your response to treatment was formally assessed using standard imaging criteria **You may NOT be eligible if...** - Your stored blood samples are of insufficient quality or quantity - Your cancer was not an adenocarcinoma (a different cancer cell type) - You had another concurrent cancer requiring systemic treatment - You have an active autoimmune or inflammatory disease that could affect the DNA markers being studied Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTcfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)

Genome-wide profiling of cfDNA methylation and hydroxymethylation from pre-treatment plasma to identify molecular determinants associated with chemotherapy efficacy (PFS ≥ 12M vs \< 12M).

DIAGNOSTIC_TESTEpiCORE Assay (Targeted Sequencing / qPCR Validation)

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.


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07224815


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