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

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.

Study Overview

• Status: Recruiting
• Conditions: Clear Cell Renal Cell Carcinoma
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nicolas MOTTET, MD PhD; Phone Number: +33 (0)477828331; Email: nicolas.mottet@chu-st-etienne.fr
• Study Contact Backup: Name: Arnauld GARCIN, CRA; Phone Number: +33 (0)477120286; Email: Arnauld.Garcin@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France
    • Recruiting
    • CHU Saint-Etienne
    • Principal Investigator: Nicolas MOTTET, MD PhD
    • Sub-Investigator: Mohammed Amine MESSAOUD, MD
    • Sub-Investigator: Hocine HABCHI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

60 patients and 40 control will be included.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Study Chair: Nora MALLOUK, PhD, UNIVERSITY SAINT-ETIENNE; Study Chair: Guorong LI, PhD, Chu de Saint-Etienne; Principal Investigator: Nicolas MOTTET, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Publications and helpful links

General Publications

• Li G, Mallouk N, Flandrin P, Garcin A, Lambert C, Berremila SA, Habchi H, Mottet N. Presence of Urinary Exosomes for Liquid Biopsy of Clear Cell Renal Cell Carcinoma: Protocol for a Pilot Feasibility Study. JMIR Res Protoc. 2021 Jul 20;10(7):e24423. doi: 10.2196/24423.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Detection; Flow cytometry; Clear cell renal cell carcinoma; RT-qPCR; Urinary exosomes; Electron microscopy technique
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 19CH048; 2019-A01408-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No