Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Recruiting

• Conditions: Clear Cell Renal Cell Carcinoma
• Interventions: Biological: Urinary sample

• Registration Number: NCT04053855
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.

Detailed Description

The primary objective is to detect urinary exosomes, by electron microscopy technique, from clear cell renal cell carcinoma due to exosome markers (CD9) and clear cell kidney cancer (CA9).

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2020-01-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

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

Inclusion Criteria

Patients:

• All patients with renal mass requiring surgery (partial or total nephrectomy)
• Social security affiliation
• Signed informed consent

Control :

• Unscheduled nephrectomy
• Social security affiliation
• Signed informed consent

Exclusion Criteria

• Insufficient volume of urine sample (< 100 ml)
• Patients with a urinary catheter
• Patients under court-ordered guardianship or curators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal mass patients	Urinary sample	Patients with renal mass requiring surgery (partial or total nephrectomy) will be included. They will have an urinary sample.
Control patients	Urinary sample	Control patients (without renal mass) will be included. They will have an urinary sample.

Primary Outcome Measures

Name	Time	Method
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.

Secondary Outcome Measures

Name	Time	Method
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients	At inclusion	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients	At inclusion	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients	Years: 2	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer	Years: 2	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients	At inclusion	Measured by analysis in flow cytometry of urinary sample.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France