Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of blood MSI detected by NGS
研究概览
简要总结
To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer.
详细描述
NGS can not only detect tissue samples, but also blood samples. For some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. It is of great significance for the diagnosis and treatment of these patients to determine MSI status by blood testing. In addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. Among them, 30 patients with MSI-H and 20 patients with MSS confirmed by IHC/PCR.The investigators will use 520 gene panel for NGS sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of NGS in detecting Microsatellite State in blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age (>18 years old).
- •Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
- •The status of dMMR/pMMR was confirmed by IHC/PCR.
- •with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
- •Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.
排除标准
- •Suffering from other malignant tumors at the same time.
- •Others that the investigator consider that is inappropriate for this study.
研究组 & 干预措施
MSI-H
IHC/PCR tested as dMMR/ MSI-H
干预措施: Next generation sequencing (Diagnostic Test)
MSS
IHC/PCR tested as pMMR/ MSS
干预措施: Next generation sequencing (Diagnostic Test)
结局指标
主要结局
Sensitivity and specificity of blood MSI detected by NGS
时间窗: 1 year
To study the sensitivity and specificity of blood MSI detected by NGS.
次要结局
- Correlation between MMR gene and other gene mutations(1 year)
- Ideal sequencing depth of MSI in blood test(1 year)
- Correlation between MSI status and TMB(1 year)
研究者
Yunpeng Liu
Director
China Medical University, China