RecruitingNCT07283575

Using ctDNA Methylation to Monitor Metastatic Colorectal Cancer Treatment (PROMET)

ctDNA Methylation for Efficacy Assessment and Prognostic Prediction in Advanced Colorectal Cancer Treated With Radiotherapy Combined With or Without PD-1 Inhibitor: A Prospective Cohort Study (PROMET)


Sponsor

Fudan University

Enrollment

497 participants

Start Date

Oct 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Multi-center observational clinical study to evaluate the application value of ctDNA methylation monitoring in efficacy assessment and relapse prediction in patients diagnosed with recurrence or metastatic colorectal cancer receiving radiotherapy plus SOC with or without PD-1.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether measuring methylation patterns in circulating tumor DNA (cancer DNA found in the bloodstream) can help doctors better track how well treatment is working in patients with metastatic or recurrent colorectal cancer. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have recurrent or metastatic colorectal cancer - You are eligible to receive radiation therapy combined with standard chemotherapy, with or without immunotherapy (PD-1 inhibitors) - You are expected to survive at least 6 months - You (or your legal representative) are willing to sign an informed consent form **You may NOT be eligible if...** - You received a blood transfusion during surgery or within 2 weeks before the study - You are pregnant or breastfeeding without using adequate contraception - You have a history of other cancers - Your condition or treatment plan does not meet the study's requirements Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPlasma ctDNA methylation profiling

Plasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07283575