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

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05705583

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Other: Other: Blood and Urine Collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	An Zhao	Hangzhou		China	310022

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ZHAO An, Zhejiang Cancer Hospital, Zhejiang Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05705583

Other Study ID Numbers:

RCC-CDx-001

First Posted:

Jan 31, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Renal Cell

Study Results

No Results Posted as of Jan 31, 2023