Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma Clinical Trial

— PEP-C  

Official title:

Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04053855
• Other study ID #: 19CH048
• Secondary ID: 2019-A01408-49
• Status: Recruiting
• Start date: January 29, 2020
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Nicolas MOTTET, MD PhD
• Phone: (0)477828331
• Email: nicolas.mottet[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients:

• All patients with renal mass requiring surgery (partial or total nephrectomy)

• Social security affiliation

• Signed informed consent

Control :

• Patients hospitalized in the urology department without cancer and without known renal mass

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Biological:
• Urinary sample
Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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