PEP-C: Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04053855

Collaborator

(none)

100

Enrollment

Location

54.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clear Cell Renal Cell Carcinoma	Biological: Urinary sample

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Actual Study Start Date :

Jan 29, 2020

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Renal mass patients Patients with renal mass requiring surgery (partial or total nephrectomy) will be included. They will have an urinary sample.	Biological: Urinary sample Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
Control patients Control patients (without renal mass) will be included. They will have an urinary sample.	Biological: Urinary sample Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.

Arm

Intervention/Treatment

Renal mass patients

Patients with renal mass requiring surgery (partial or total nephrectomy) will be included. They will have an urinary sample.

Biological: Urinary sample

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

Control patients

Control patients (without renal mass) will be included. They will have an urinary sample.

Biological: Urinary sample

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

Outcome Measures

Primary Outcome Measures

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

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 electron microscopy technique (%) for control patients [At inclusion]
Measured by analysis in electron microscopy technique of urinary sample.
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+ /CA9+ exosomes by flow cytometry (%) for control patients [At inclusion]
Measured by analysis in flow cytometry 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+ /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 patients with clear cell kidney cancer [At inclusion]
Measured by analysis in electron microscopy technique 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+/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+/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+/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 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 patients with clear cell kidney cancer [At inclusion]
Measured by analysis in flow cytometry 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.
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+/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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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