NCT07254156

A Study of Tumor-Agnostic MRD Detection in Stage III Colorectal Cancer

A Prospective, Multicenter, Exploratory Clinical Study Evaluating the Application of Tissue-Agnostic Technology in the Dynamic Monitoring of Minimal Residual Disease in Stage III Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 229 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study aims to evaluate the predictive performance of various omics-based methods for detecting minimal residual disease (MRD) in stage III colorectal cancer. The study involves the collection of blood samples from patients who have accepted surgery for colorectal cancer. Blood samples will be analyzed using both tumor-informed and tumor-agnostic approaches to detect circulating tumor DNA (ctDNA). The study will compare the sensitivity of these methods and assess their correlation with recurrence risk. The findings aim to inform the development of optimal MRD detection strategies, ultimately providing a robust molecular basis for personalized treatment decisions.

Conditions

• Colorectal Cancer
• MRD
• ctDNA

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRD detection	Baseline blood samples, surgical resected tumor tissue, blood samples after surgery, and blood samples after adjuvant therapy will be collected from colorectal patients. MRD will be assessed using both tumor-informed and tumor-agnostic methods.

Timeline

• Start date: 2025-11-24
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: China