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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- The predictive role of MRD in prognosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Willing and able to provide signed informed consent for participation in the study.
排除标准
- •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.
结局指标
主要结局
The predictive role of MRD in prognosis
时间窗: 3 years
The survival difference between MRD positive and MRD negative patients.
次要结局
- The positive detection rate of baseline ctDNA(1 year)
- Predictive Accuracy of MRD for Recurrence(3 years)
研究者
Feng Wang
Professor
Sun Yat-sen University