RecruitingNCT07224841

Development of a cfDNA 5mC/5hmC-based Biomarker Panel to Predict Targeted Therapy Efficacy in mCRC

Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Identify Determinants of Response In VEGF/EGFR-targeted Therapy for Metastatic Colorectal Cancer


Sponsor

City of Hope Medical Center

Enrollment

500 participants

Start Date

Jun 21, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The EpiDRIVE study aims to identify cfDNA-based epigenetic determinants of response in metastatic colorectal cancer (mCRC) patients treated with EGFR- or VEGF-targeted therapy. By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to develop a predictive biomarker panel capable of differentiating responders from non-responders to targeted therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using stored blood samples from people with metastatic colorectal cancer to see whether specific chemical tags on tumor DNA in the blood (5mC and 5hmC markers) can predict how well a patient responds to targeted therapies — either drugs that block a protein called EGFR (cetuximab or panitumumab) or drugs that block blood vessel growth (bevacizumab). **You may be eligible if...** - You have confirmed metastatic colorectal adenocarcinoma - You received EGFR-targeted therapy (cetuximab or panitumumab) or VEGF-targeted therapy (bevacizumab) - Pre-treatment plasma samples for DNA analysis are available - Your RAS and BRAF mutation status is documented - Your treatment response was formally assessed on scans **You may NOT be eligible if...** - Your stored blood samples are of low quality or insufficient quantity - Your cancer was not an adenocarcinoma histology - You have another active concurrent cancer - You have an active autoimmune or inflammatory disease that could distort the DNA methylation results 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 (EpiDRIVE Discovery Phase)

High-throughput genome-wide sequencing of cfDNA methylation (5mC) and hydroxymethylation (5hmC) profiles from pre-treatment plasma samples in the discovery cohort to identify epigenetic determinants of targeted-therapy response (PFS ≥ 12 months vs \< 12 months).

DIAGNOSTIC_TESTEpiDRIVE Assay (Targeted Sequencing / qPCR Validation)

Targeted sequencing or qPCR-based validation of cfDNA 5mC/5hmC markers identified from the discovery phase to develop and validate a predictive biomarker model discriminating patients with long vs short progression-free survival after EGFR-/VEGF-targeted therapy.


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07224841


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