A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma

Zhejiang Cancer Hospital100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Renal Cell Carcinoma

Interventions

Other: Blood and Urine CollectionOTHER

Blood and Urine Collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

An Zhao

Hangzhou, China

RECRUITING

Outcomes

Primary Outcomes

The correlation between the circulating exosomes levels and the tumor responsiveness

The Measurement： The concentration of ciruculating exosomes and the expression level of exosomal RNA. The Measurement Tool: RT-PCR，WB and Elisa

Time frame: 3 years

Data from ClinicalTrials.gov

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