Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Incidence of MSI-H across different cancer types in Chinese patients
研究概览
简要总结
This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.
详细描述
This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female, age≥18 years old.
- •Confirmed malignant solid tumor by histopathology or cytopathology.
- •Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
- •Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
- •Signed the informed consent with name and time.
排除标准
- •Hematological malignancy
- •Patients who received immuotherapies.
- •Patients who received blood transfusion within one month before blood collection.
研究组 & 干预措施
Experimental group
A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing.
干预措施: SPANOM (identifying MSI status from ctDNA) (Diagnostic Test)
结局指标
主要结局
Incidence of MSI-H across different cancer types in Chinese patients
时间窗: Two years
次要结局
- Incidence of Lynch syndrome across different cancer types(Two years)
- Concordance between blood-MSI and corresponding tissue-MSI status(Two years)
研究者
Shen Lin
Professor
Peking University