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

January 30, 2023 updated by: ZHAO An, Zhejiang Cancer Hospital

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 Overview

Status

Recruiting

Conditions

Renal Cell Carcinoma

Intervention / Treatment

Other: Other: Blood and Urine Collection

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hangzhou, China, 310022
    - Recruiting
    - An Zhao
    - Contact:
      
      An Zhao, Dr
      
      Phone Number: +8618258863556
      
      Email: zhaoan@zjcc.org.cn
    - Principal Investigator:
      
      An Zhao, PHD
    - Principal Investigator:
      
      Zongping Wang, MD
    - Principal Investigator:
      
      Yipeng Xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with renal cell carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)