Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients with renal mass requiring surgery (partial or total nephrectomy)

Social security affiliation

Signed informed consent

Unscheduled nephrectomy

Disqualifiers

Insufficient volume of urine sample (< 100 ml)

Patients with a urinary catheter

Patients under court-ordered guardianship or curators

Trial population

60 patients and 40 control will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Urinary sample

    Biological/Vaccine

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Renal mass patients1 intervention
Group B: Control patients1 intervention

Trial outcomes

Primary outcomes

1

Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique

Measured by analysis in electron microscopy technique of urinary sample.

Time frame
At inclusion

Secondary outcomes

1

Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer

Measured by analysis in electron microscopy technique of urinary sample.

Time frame
At inclusion
2

Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients

Measured by analysis in electron microscopy technique of urinary sample.

Time frame
At inclusion
3

Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer

Measured by analysis in flow cytometry of urinary sample.

Time frame
At inclusion
4

Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients

Measured by analysis in flow cytometry of urinary sample.

Time frame
At inclusion

Other outcomes

Sponsors and contacts

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