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Clinical Trials/NCT04053855
NCT04053855
Recruiting
Not Applicable

Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country100 target enrollmentJanuary 29, 2020

Overview

Phase
Not Applicable
Intervention
Urinary sample
Conditions
Clear Cell Renal Cell Carcinoma
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
100
Locations
1
Primary Endpoint
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 29, 2020
End Date
August 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Arms & Interventions

Renal mass patients

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

Intervention: Urinary sample

Control patients

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

Intervention: Urinary sample

Outcomes

Primary Outcomes

Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique

Time Frame: At inclusion

Measured by analysis in electron microscopy technique of urinary sample.

Secondary Outcomes

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

Study Sites (1)

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