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Recruiting NCT07224841

NCT07224841 Development of a cfDNA 5mC/5hmC-based Biomarker Panel to Predict Targeted Therapy Efficacy in mCRC

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Clinical Trial Summary
NCT ID NCT07224841
Status Recruiting
Phase
Sponsor City of Hope Medical Center
Condition CRC (Colorectal Cancer)
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2024-06-21
Primary Completion 2026-06-18

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
cfDNA 5mC/5hmC Sequencing (EpiDRIVE Discovery Phase)EpiDRIVE Assay (Targeted Sequencing / qPCR Validation)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 500 participants in total. It began in 2024-06-21 with a primary completion date of 2026-06-18.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma (mCRC). * Received EGFR-targeted therapy (cetuximab/panitumumab) or VEGF-targeted therapy (bevacizumab). * Availability of pre-treatment plasma sample for cfDNA analysis. * Documented radiologic response evaluation (RECIST 1.1). * RAS/BRAF mutation status known. Exclusion Criteria: * Inadequate cfDNA quality or low cfDNA yield. * Non-adenocarcinoma histology. * Concurrent or prior other active malignancy. * Active inflammatory or autoimmune disease affecting cfDNA methylation profiles.

Contact & Investigator

Central Contact

Ajay Goel, PhD

✉ ajgoel@coh.org

📞 626-359-8111

Principal Investigator

Ajay Goel, PhD

PRINCIPAL INVESTIGATOR

City of Hope Medical Center

Frequently Asked Questions

Who can join the NCT07224841 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying CRC (Colorectal Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07224841 currently recruiting?

Yes, NCT07224841 is actively recruiting participants. Contact the research team at ajgoel@coh.org for enrollment information.

Where is the NCT07224841 trial being conducted?

This trial is being conducted at Duarte, United States.

Who is sponsoring the NCT07224841 clinical trial?

NCT07224841 is sponsored by City of Hope Medical Center. The principal investigator is Ajay Goel, PhD at City of Hope Medical Center. The trial plans to enroll 500 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology