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

N/ANot Yet RecruitingNCT07254156

Sun Yat-sen University229 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

229

Conditions

Colorectal Cancer MRD ctDNA

Interventions

MRD detectionDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The predictive role of MRD in prognosis

The survival difference between MRD positive and MRD negative patients.

Time frame: 3 years

Secondary Outcomes

The positive detection rate of baseline ctDNA

Time frame: 1 year

Predictive Accuracy of MRD for Recurrence

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