Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MSI status in blood sample
研究概览
简要总结
The method to analyze the microsatellite instability (MSI) status by next-generation sequencing (NGS) has been established to assess the deficiency of DNA mismatch repair (MMR) system. The aim of our study is to evaluate the feasibility and reliability of this NGS method by testing the circulating tumor DNA (ctDNA) in blood sample of advanced colorectal cancer patients. If the result is positive, the MSI status could be easily learned without the acquisition of tissue samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •a biopsy proven histological diagnosis of colorectal carcinoma
- •MSI status of tissue sample known by IHC or PCR method
- •willing to participate and informed consent signed
排除标准
- •history of other malignant tumors
- •patients with inflammatory bowel disease
- •patients with familial adenomatous polyposis
- •patients treated by surgery or adjuvant treatment
- •pregnant or lactating women
结局指标
主要结局
MSI status in blood sample
时间窗: through study completion, an average of 1 year
ctDNA and leucocyte are extracted from blood sample for MSI detection by ColonCore NGS panel (Burning Rock, Guangzhou, China). There are three types of MSI status, MSI-H, MSI-L and MSS.
次要结局
未报告次要终点