Clinical trial NCT04053855: Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
Official title: Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clear Cell Renal Cell Carcinoma
Keywords: Clear cell renal cell carcinoma
Urinary exosomes
Detection
Electron microscopy technique
Flow cytometry
RT-qPCR
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients and 40 control will be included.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
timeFrame: At inclusion
Secondary outcomes:
measure: Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
timeFrame: Years: 2
measure: Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
timeFrame: Years: 2
measure: Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients
timeFrame: At inclusion
measure: Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer
timeFrame: At inclusion
measure: Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients
timeFrame: At inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Nicolas MOTTET, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY SAINT-ETIENNE
name: Nora MALLOUK, PhD
role: STUDY_CHAIR
affiliation: CHU DE SAINT-ETIENNE
name: Guorong LI, PhD
role: STUDY_CHAIR
References:
citation: 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.