Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urinary sample.
- Who it may be relevant to
- Registry conditions: Clear Cell Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological Urinary sample
Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
Primary outcome measures
- Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique [Time frame: At inclusion]
Secondary outcome measures (12)
- Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer [Time frame: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients [Time frame: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer [Time frame: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients [Time frame: At inclusion]
- Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients [Time frame: At inclusion]
- 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]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer [Time frame: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients [Time frame: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer [Time frame: At inclusion]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients [Time frame: 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 [Time frame: Years: 2]
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients [Time frame: Years: 2]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu Saint-Etienne — Saint-Etienne
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. PMID 34283029
Identifiers
NCT: NCT04053855 · 19CH048 · 2019-A01408-49