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NCT Number: NCT04053855

Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

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.

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Key information

Conditions

Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

Location contact

Hocine HABCHI, MD

SUB_INVESTIGATOR

Mohammed Amine MESSAOUD, MD

SUB_INVESTIGATOR

Nicolas MOTTET, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urinary sample

Biological

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

Primary outcomes

  1. 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

  1. Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in electron microscopy technique of urinary sample.

  2. Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients

    Time frame: At inclusion

    Measured by analysis in electron microscopy technique of urinary sample.

  3. Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in flow cytometry of urinary sample.

  4. Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients

    Time frame: At inclusion

    Measured by analysis in flow cytometry of urinary sample.

  5. Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients

    Time frame: At inclusion

    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

  6. Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

  7. Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in electron microscopy technique of urinary sample.

  8. Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients

    Time frame: At inclusion

    Measured by analysis in electron microscopy technique of urinary sample.

  9. Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in flow cytometry of urinary sample.

  10. Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients

    Time frame: At inclusion

    Measured by analysis in flow cytometry of urinary sample.

  11. Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer

    Time frame: Years: 2

    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

  12. Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients

    Time frame: Years: 2

    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

  13. Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in electron microscopy technique of urinary sample.

  14. Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients

    Time frame: At inclusion

    Measured by analysis in electron microscopy technique of urinary sample.

  15. Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in flow cytometry of urinary sample.

  16. Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients

    Time frame: At inclusion

    Measured by analysis in flow cytometry of urinary sample.

  17. Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer

    Time frame: At inclusion

    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

  18. Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients

    Time frame: At inclusion

    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

Study contacts

Contact information is provided by the study sponsor or research team.

Arnauld GARCIN, CRA

CONTACT

[email protected]

(0)477120286 ext. +33

Nicolas MOTTET, MD PhD

CONTACT

[email protected]

(0)477828331 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PEP-C

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2019
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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