Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Conditions
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Clear Cell Renal Cell Carcinoma

Intervention / Treatment
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* Biological: Urinary sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients | Measured by analysis in electron microscopy technique of urinary sample. | At inclusion | 
| 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 | 
| Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients | Measured by analysis in flow cytometry of urinary sample. | At inclusion | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients | Measured by analysis in flow cytometry of urinary sample. | At inclusion | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients | Measured by analysis in electron microscopy technique of urinary sample. | At inclusion | 
| 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 | 
| Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients | Measured by analysis in flow cytometry of urinary sample. | At inclusion | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clear cell renal cell carcinoma, Urinary exosomes, Detection, Electron microscopy technique, Flow cytometry, RT-qPCR