MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-III)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 390
- 主要终点
- Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma
研究概览
简要总结
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with stage I-III operable colon adenocarcinoma. MRD refers to the presence of cancer cells that remain in the body after treatment but are undetectable by traditional imaging methods. The study will use a blood-based test to detect circulating tumor DNA (ctDNA) and assess its ability to predict cancer recurrence and survival outcomes.
Patients who are newly diagnosed with stage I-III colon adenocarcinoma and are eligible for surgery will be enrolled. Blood samples will be collected at multiple time points, including before surgery, after surgery, and during follow-up visits over three years. The study will compare MRD status with recurrence-free survival (RFS), overall survival (OS), and the time it takes for MRD to detect recurrence compared to standard imaging methods.
The goal is to determine whether MRD monitoring can provide early warning of cancer recurrence and help guide treatment decisions. This study may offer valuable insights into improving postoperative surveillance and personalized treatment strategies for colon cancer patients.
详细描述
This is a multicenter, prospective, observational study designed to evaluate the effectiveness of ctDNA-based MRD monitoring in predicting disease recurrence and survival outcomes in patients with stage I-III operable colon adenocarcinoma. The study will enroll 390 patients who have not previously received chemotherapy, radiotherapy, or targeted therapy.
Key Objectives:
Primary Objective:
To explore the correlation between MRD status and recurrence-free survival (RFS) in stage I-III colon adenocarcinoma patients.
Secondary Objectives:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-80 years old, male or female not limited;
- •Histologically confirmed colon adenocarcinoma (i.e. adenocarcinoma, including adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, undifferentiated carcinoma; excluding adenosquamous cell carcinoma);
- •Preoperative staging of stages I-III, without undergoing endoscopic ESD or EMR surgical resection;
- •Not receiving chemotherapy, radiotherapy, targeted therapy, or other anti-tumor treatments;
- •Radical surgery can be performed;
- •ECOG score 0-1 points;
- •The subjects voluntarily joined this study and signed an informed consent form, demonstrating good compliance and actively cooperating to return to the hospital for regular clinical follow-up diagnosis and treatment.
排除标准
- •Previously suffered from other malignant tumors (including non adenocarcinoma colorectal cancer);
- •Pregnant and lactating women;
- •According to the researchers' assessment, the patient also suffers from other diseases that may affect follow-up and short-term survival
- •Subjects have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental illness, infectious diseases, fever ≥ 38 ℃, etc.) requiring combined treatment, serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of subjects, or the collection of data and samples.
结局指标
主要结局
Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma
时间窗: From surgery until disease recurrence or up to 36 months, whichever occurs first
Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma
次要结局
- The correlation between MRD status and 1-year recurrence free survival (1yRFS)(From surgery until 12 months post-surgery)
- The correlation between MRD status and 2-year recurrence free survival (2yRFS)(From surgery until 24 months post-surgery)
- The correlation between MRD status and overall survival (OS)(From surgery until death or up to 36 months, whichever occurs first)
研究者
Xu jianmin
Director of Colorectal Surgery Department, Zhongshan hospital, Fudan University
Fudan University