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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

Tracking Information
First Submitted Date August 9, 2019
First Posted Date August 13, 2019
Last Update Posted Date August 13, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 12, 2019)
  • 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.
  • 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.
  • 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.
  • Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At inclusion ]
    Measured by analysis in flow cytometry of urinary sample.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At inclusion ]
    Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
Official Title Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urinary sample
Sampling Method Non-Probability Sample
Study Population 60 patients and 40 control will be included.
Condition Clear Cell Renal Cell Carcinoma
Intervention Biological: Urinary sample
Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
Study Groups/Cohorts
  • Renal mass patients

    Patients with renal mass requiring surgery (partial or total nephrectomy) will be included.

    They will have an urinary sample.

    Intervention: Biological: Urinary sample
  • Control patients
    Control patients (without renal mass) will be included. They will have an urinary sample.
    Intervention: Biological: Urinary sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 12, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04053855
Other Study ID Numbers 19CH048
2019-A01408-49 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Not Provided
Investigators
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
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date August 2019