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NCT Number: NCT07254156

A Study of Tumor-Agnostic MRD Detection 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms CtDNA Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms MRD Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The predictive role of MRD in prognosis

    Time frame: 3 years

    The survival difference between MRD positive and MRD negative patients.

Secondary outcomes

  1. The positive detection rate of baseline ctDNA

    Time frame: 1 year

  2. Predictive Accuracy of MRD for Recurrence

    Time frame: 3 years

    Sensitivity, Specificity, Positive predictive value, and Negative predictive value of ctDNA-MRD in predicting postoperative recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Wang

CONTACT

[email protected]

+86-020-8734-3571

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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