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临床试验/NCT03561350
NCT03561350Unknown不适用

Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing

Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月28日最近更新:
适应症

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

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

研究者

发起方
Shanghai Minimally Invasive Surgery Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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