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

NCT ID: NCT07254156

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 229 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-24
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with stage III colorectal cancer

MRD detection

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Histologically confirmed colorectal cancer.
• Preoperatively assessed as stage III according to the 8th edition UICC/AJCC staging system.
• Deemed eligible for radical resection upon investigator assessment.
• No prior anti-tumor therapy received.
• ECOG PS score 0-1.
• Willing and able to provide signed informed consent for participation in the study.

Exclusion Criteria

• Has a history of other malignant tumors.
• Pregnant and lactating women.
• Presence of any concurrent medical or psychiatric condition, as assessed by the investigator, that may interfere with protocol compliance, study follow-up, or affect short-term survival.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Feng Wang

Role: CONTACT

wangfeng@sysucc.org.cn

+86-020-8734-3571

Facility Contacts

Zhida Lv

Role: primary

lvzd@sysucc.org.cn

+86-020-8734-2635

Other Identifiers

TRACE-CRC

Identifier Type: -

Identifier Source: org_study_id