Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04053855

Acronym

PEP-C

Enrollment

100

Registered

2019-08-13

Start date

2020-01-29

Completion date

2026-08-01

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Clear cell renal cell carcinoma, Urinary exosomes, Detection, Electron microscopy technique, Flow cytometry, RT-qPCR

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).

Interventions

BIOLOGICALUrinary sample

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.

Secondary

Measure	Time frame	Description
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients	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	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients	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	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	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	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	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	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients	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	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	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	At inclusion	Measured by analysis in electron microscopy technique of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients	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	At inclusion	Measured by analysis in flow cytometry of urinary sample.
Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients	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	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	At inclusion	Measured by analysis in Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) of urinary sample.

Countries

France

Contacts

CONTACTNicolas MOTTET, MD PhD

nicolas.mottet@chu-st-etienne.fr(0)477828331

CONTACTArnauld GARCIN, CRA

Arnauld.Garcin@chu-st-etienne.fr(0)477120286

PRINCIPAL_INVESTIGATORNicolas MOTTET, MD PhD

Centre Hospitalier Universitaire de Saint Etienne

STUDY_CHAIRNora MALLOUK, PhD

UNIVERSITY SAINT-ETIENNE

STUDY_CHAIRGuorong LI, PhD

CHU DE SAINT-ETIENNE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026