Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

NCT04053855 | Recruiting

• 2 other identifiers: 19CH0482019-A01408-49
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Clear cell renal cell carcinoma; Urinary exosomes; Detection; Electron microscopy technique; Flow cytometry; RT-qPCR

Outcome Measures

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.

  At inclusion

Secondary Outcomes (18)

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

  At inclusion

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

  At inclusion

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

  At inclusion

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

  At inclusion

• Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients

  At inclusion

Study Arms (2)

Renal mass patients

Patients with renal mass requiring surgery (partial or total nephrectomy) will be included. They will have an urinary sample.

Biological: Urinary sample

Control patients

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

Biological: Urinary sample

Interventions

Urinary sample BIOLOGICAL

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

Control patients; Renal mass patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients and 40 control will be included.

You may qualify if:

• 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

You may not qualify if:

• Insufficient volume of urine sample (\< 100 ml)
• Patients with a urinary catheter
• Patients under court-ordered guardianship or curators

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary sample

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Nicolas MOTTET, MD PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

• Nora MALLOUK, PhD

  UNIVERSITY SAINT-ETIENNE

  STUDY CHAIR

• Guorong LI, PhD

  CHU DE SAINT-ETIENNE

  STUDY CHAIR

Central Study Contacts

Nicolas MOTTET, MD PhD

CONTACT

(0)477828331; nicolas.mottet@chu-st-etienne.fr

Arnauld GARCIN, CRA

CONTACT

(0)477120286; Arnauld.Garcin@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: January 29, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)