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

Recruiting

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT05705583
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Advanced Metastatic RCC
• Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
• Age >= 18 years
• Able to provide informed consent

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Exclusion Criteria

• Other, unrelated, concomitant active, invasive malignancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlation between the circulating exosomes levels and the tumor responsiveness	3 years	The Measurement： The concentration of ciruculating exosomes and the expression level of exosomal RNA.; The Measurement Tool: RT-PCR，WB and Elisa

Trial Locations

Locations (1)

An Zhao; 🇨🇳 Hangzhou, China