Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo.
研究概览
简要总结
The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological histology and/or cytology confirmed malignant tumor;
- •Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
排除标准
- •Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
- •Patients with a history of autoimmune disease;
- •Patients with participating in other clinical trials at the same time;
- •Other cases that researchers believe that patients should not participate in the present trial.
结局指标
主要结局
The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo.
时间窗: up to one and a half years
次要结局
- The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.(up to one and a half years)
研究者
Jianguo Sun
Deputy Director
Xinqiao Hospital of Chongqing