A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The correlation between the circulating exosomes levels and the tumor responsiveness
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
ZHAO An
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Advanced Metastatic RCC
- •Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
- •Age \>= 18 years
- •Able to provide informed consent
Exclusion Criteria
- •Other, unrelated, concomitant active, invasive malignancy
Outcomes
Primary Outcomes
The correlation between the circulating exosomes levels and the tumor responsiveness
Time Frame: 3 years
The Measurement： The concentration of ciruculating exosomes and the expression level of exosomal RNA. The Measurement Tool: RT-PCR，WB and Elisa