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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Clear Cell Renal Cell Carcinoma

Treatments

Biological: Urinary sample

Study type

Observational

Funder types

Other

Identifiers

NCT04053855
19CH048
2019-A01408-49 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Renal mass patients
Description:
Patients with renal mass requiring surgery (partial or total nephrectomy) will be included. They will have an urinary sample.
Treatment:
Biological: Urinary sample
Control patients
Description:
Control patients (without renal mass) will be included. They will have an urinary sample.
Treatment:
Biological: Urinary sample

Trial contacts and locations

1

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Central trial contact

Arnauld GARCIN, CRA; Nicolas MOTTET, MD PhD

Data sourced from clinicaltrials.gov

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