the Role of ctDNA in Predicting the Recurrence Risk of Stage Ⅱ and Ⅲ Colorectal Cancer and the Dynamic Changes in ctDNA of Patients With Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- ctDNA status
研究概览
简要总结
The purpose of this study was to observe the relationship between ctDNA as a molecular marker of colorectal cancer and the risk of postoperative recurrence.
详细描述
In this clinical study, ctDNA will be detected in postoperative patients with stage Ⅱ and Ⅲ colorectal cancer to evaluate the correlation between ctDNA and the risk of postoperative recurrence. According to the dynamic changes of ctDNA after adjuvant chemotherapy, the correlation between ctDNA and postoperative DFS will be compared, and the feasibility of ctDNA as a molecular marker to evaluate the risk of postoperative recurrence of colorectal cancer will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Patients with colorectal cancer diagnosed pathologically as stage Ⅱ and stage Ⅲ.
- •The patient underwent radical surgical treatment.
- •The patient has the results of genetic genetic testing for gastrointestinal tumors, including the genetic mutation status of MMR genes and related genes (MLH1, MSH2, MSH6, PMS2, MLH3, EPCAM).
- •The patient understands and is willing to sign a written informed consent document.
- •During the treatment process, the patient can cooperate to provide samples of each node.
- •The patient can provide corresponding clinical materials, including but not limited to case diagnosis, imaging evaluation, and serum protein marker test results.
排除标准
- •The patient cannot provide a complete and qualified specimen.
- •The patient has other primary malignant tumors or serious medical illnesses.
- •The patient cannot cooperate with the follow-up.
- •Conditions that other researchers deemed inappropriate for continuing to participate in the study.
结局指标
主要结局
ctDNA status
时间窗: Two weeks
Detect postoperative tissue ctDNA status
ctDNA dynamic detection
时间窗: 6 months
ctDNA dynamic monitoring during postoperative adjuvant chemotherapy
次要结局
- Tumor Marker examination(6 months)
- Imaging examination(6 months)