Based on the Application of Peripheral Blood Polygene Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 7
- 主要终点
- To establish a clinical cohort for colorectal cancer
研究概览
简要总结
This study dynamically monitored the prognosis of stage I-IV colorectal cancer patients who could receive radical surgical resection by detecting the levels of polygene methylation in plasma samples from patients with colorectal cancer. In patients with colorectal cancer feasible radical surgery, plasma ctDNA methylation detection was performed before and after surgical treatment and during regular follow-up to explore the predictive effect of plasma ctDNA methylation status at different time points on postoperative recurrence. To explore whether postoperative dynamic monitoring of plasma ctDNA methylation can be used for adjuvant chemotherapy efficacy evaluation and whether it can indicate tumor recurrence and metastasis earlier than imaging examination.
详细描述
- Patients initially diagnosed with primary colorectal cancer were enrolled for screening, and plasma samples 1-2 days before radical bowel resection were collected for polygene methylation detection.
- The postoperative follow-up was 2 years, and the reexamination included CT/MRI imaging assessment, blood CEA, and dynamic monitoring of plasma ctDNA methylation level. Blood samples were collected for 9 times.
- Results analysis: To explore the application value of ctDNA methylation-MRD detection in the prediction of postoperative tumor recurrence risk after radical resection of colorectal cancer; The correlation between preoperative ctDNA methylation level and prognosis of early colorectal cancer.
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
- •Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);
- •Patients diagnosed as stage I-III and feasible for radical bowel surgery;
- •Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete resection of liver metastasis;
- •No gender limitation, age ≥18;
- •ECOG score ≤1;
- •Life expectancy ≥5 years;
- •Those who fully understand the study and voluntarily sign the informed consent.
排除标准
- •Blood transfusion was performed during surgery or 2 weeks before surgery;
- •complicated with primary malignant tumors of other organs;
- •With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment;
- •Colorectal cancer was diagnosed with extrahepatic metastasis;
- •Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection;
- •Radical bowel resection was performed after endoscopic surgery;
- •Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer;
- •serious mental illness or drug abuse;
- •patients with serious heart, lung and vascular diseases who cannot tolerate surgery;
- •pregnant or lactating women;
- •Participate in other interventional clinical investigators within 3 months
- •Poor compliance, unable to complete the study according to the judgment of the researcher.
结局指标
主要结局
To establish a clinical cohort for colorectal cancer
时间窗: assessed up to 36 months
It is expected that 800 patients with primary colorectal cancer diagnosed clinically will be enrolled for screening. Plasma samples 1-2 days before radical bowel resection will be collected for ColonAiQ polygene methylation test. Follow-up will be conducted 2 years after surgical resection, including CT/MRI imaging evaluation and blood CEA, etc. And dynamic monitoring of plasma ctDNA methylation level. Blood samples were collected for 9 times.
To investigate the prediction and monitoring effect of plasma ctDNA methylation on postoperative recurrence of primary colorectal cancer patients after radical surgery
时间窗: assessed up to 36 months
To investigate the role of peripheral plasma ctDNA methylation level at different time points in the monitoring of disease recurrence after radical bowel resection for primary colorectal cancer, the multi-gene methylation detection of peripheral plasma ctDNA was conducted before, after and during the postoperative follow-up period.
次要结局
未报告次要终点