NCT07283575

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 497 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll patients with histologically confirmed, recurrent or metastatic colorectal cancer who are eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. The study will employ ctDNA methylation detection technology to quantitatively assess ctDNA methylation levels in patient plasma samples. Blood samples will be collected at baseline and at multiple predefined timepoints during treatment. In addition, participants will undergo standard imaging surveillance (CT/MRI) every three months. The study aims to correlate ctDNA dynamics with therapeutic response, time to recurrence, and survival outcomes. Ultimately, it seeks to evaluate the potential of ctDNA monitoring for predicting treatment efficacy and prognosis, and to explore its utility in guiding clinical management for metastatic colorectal cancer.

Conditions

• Metastatic Colorectal Cancer ctDNA Surveillance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Plasma ctDNA methylation profiling	Plasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay

Timeline

• Start date: 2025-10-10
• Primary completion: 2028-10-10
• Completion: 2030-10-10
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China