A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The correlation between the circulating exosomes levels and the tumor responsiveness
研究概览
简要总结
Immune checkpoint inhibitors targeting PD-1 or PD-L1 have been developed and clinical trials showning better response in unselected patients with metastatic renal cell carcinoma (RCC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 RCC responsiveness. The objective of this study is to develop and evaluate the utility of circulating exosomes as companion diagnostic biomarker for predicting response to immunotherapy in patients with RCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Advanced Metastatic RCC
- •Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
- •Age >= 18 years
- •Able to provide informed consent
排除标准
- •Other, unrelated, concomitant active, invasive malignancy
结局指标
主要结局
The correlation between the circulating exosomes levels and the tumor responsiveness
时间窗: 3 years
The Measurement： The concentration of ciruculating exosomes and the expression level of exosomal RNA. The Measurement Tool: RT-PCR，WB and Elisa
次要结局
未报告次要终点
研究者
ZHAO An
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital