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

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ClinicalTrials.gov Identifier: NCT04053855
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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
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).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Urinary sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 patients and 40 control will be included.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053855


Contacts
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Contact: Nicolas MOTTET, MD PhD (0)477828331 ext +33 nicolas.mottet@chu-st-etienne.fr
Contact: Arnauld GARCIN, CRA (0)477120286 ext +33 Arnauld.Garcin@chu-st-etienne.fr

Locations
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France
Chu Saint-Etienne Not yet recruiting
Saint-Étienne, France
Principal Investigator: Nicolas MOTTET, MD PhD         
Sub-Investigator: Hocine HABCHI, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Nicolas MOTTET, MD PhD CHU SAINT-ETIENNE
Study Chair: Nora MALLOUK, PhD UNIVERSITY SAINT-ETIENNE
Study Chair: Guorong LI, PhD CHU DE SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04053855     History of Changes
Other Study ID Numbers: 19CH048
2019-A01408-49 ( Other Identifier: ANSM )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Clear cell renal cell carcinoma
Urinary exosomes
Detection
Electron microscopy technique
Flow cytometry
RT-qPCR
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases