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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; MRD; ctDNA
• Intervention / Treatment: Diagnostic test: MRD detection

• Study Type: Observational
• Enrollment (Estimated): 229

Contacts and Locations

• Study Contact: Name: Feng Wang; Phone Number: +86-020-8734-3571; Email: wangfeng@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
      • Contact: Zhida Lv; Phone Number: +86-020-8734-2635; Email: lvzd@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with stage III colorectal cancer	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predictive role of MRD in prognosis	The survival difference between MRD positive and MRD negative patients.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The positive detection rate of baseline ctDNA		1 year
Predictive Accuracy of MRD for Recurrence	Sensitivity, Specificity, Positive predictive value, and Negative predictive value of ctDNA-MRD in predicting postoperative recurrence	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): November 24, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: TRACE-CRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No