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

NCT07254156 | Not Yet Recruiting

• 1 other identifier: TRACE-CRC
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The predictive role of MRD in prognosis

  The survival difference between MRD positive and MRD negative patients.

  3 years

Secondary Outcomes (2)

• The positive detection rate of baseline ctDNA

  1 year

• Predictive Accuracy of MRD for Recurrence

  3 years

Study Arms (1)

Patients with stage III colorectal cancer

Diagnostic Test: MRD detection

Interventions

MRD detection 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.

Patients with stage III colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 229 patients newly diagnosed with stage III colorectal cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Feng Wang

CONTACT

+86-020-8734-3571; wangfeng@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (1)