Clinical trial

Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Name
19CH048
Description
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.
Trial arms
Trial start
2020-01-29
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Recruiting
Treatment
Urinary sample
Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
Arms:
Control patients, Renal mass patients
Size
100
Primary endpoint
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
At inclusion
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urinary sample'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-10-26

1 organization

1 product

1 indication