Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

NCT ID: NCT04053855

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-29

Study Completion Date

2026-08-01

Brief Summary

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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

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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).

Conditions

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Clear Cell Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal mass patients

Patients with renal mass requiring surgery (partial or total nephrectomy) will be included.

They will have an urinary sample.

Urinary sample

Intervention Type BIOLOGICAL

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

Control patients

Control patients (without renal mass) will be included. They will have an urinary sample.

Urinary sample

Intervention Type BIOLOGICAL

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

Interventions

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Urinary sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas MOTTET, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Nora MALLOUK, PhD

Role: STUDY_CHAIR

UNIVERSITY SAINT-ETIENNE

Guorong LI, PhD

Role: STUDY_CHAIR

CHU DE SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas MOTTET, MD PhD

Role: CONTACT

(0)477828331 ext. +33

Arnauld GARCIN, CRA

Role: CONTACT

(0)477120286 ext. +33

References

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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.

Reference Type DERIVED
PMID: 34283029 (View on PubMed)

Other Identifiers

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2019-A01408-49

Identifier Type: OTHER

Identifier Source: secondary_id

19CH048

Identifier Type: -

Identifier Source: org_study_id

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