UroCCR Database: French Research Network for Kidney Cancer

Kidney Cancer Clinical Trial

— UroCCR  

Official title:

UroCCR Database: French Research Network for Kidney Cancer (National Multidisciplinary Clinical and Biological Database on Kidney Cancer)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293563
• Other study ID #: CHUBX 2011/38
• Status: Recruiting
• Start date: December 2011
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: University Hospital, Bordeaux
• Contact: Jean-Christophe BERNHARD, PHU
• Phone: +33 (0)5 57 82 03 50
• Email: jean-christophe.bernhard[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Within the framework for kidney cancer care, with the recent diversification of treatment modalities of these tumors and the deployment of the concept of multidisciplinary team, it was considered necessary to adapt the research tools to reality of health-care for patients with kidney cancer.

UroCCR is the French research network for kidney cancer, funded by the French National Cancer Institute as part of the call for projects for clinical and biological databases (BCB). Depending on the case presentation and disease evolution, more than a thousand of different variables can be recorded. At the same time, biological samples (plasma, urine, healthy and tumor tissues) are collected.

This database contains a considerable number of information and high added value since it is the result of multiple expertises that make it not only a multidisciplinary tool but also multicenter, allowing fundamental, translational and clinical research.

Description:

The UroCCR database is a national medico-scientific network focused on therapeutic management and applied research in kidney cancer.

Secondary objectives:

1. - Evaluate and compare different surgical approaches in the treatment of kidney cancer,

2. - Evaluate and compare safety/efficacy of different drugs in the treatment of kidney cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient with kidney cancer

• Patient with no opposition to collection of its data for the study

Exclusion Criteria: none

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Procedure:
• Radical nephrectomy versus partial nephrectomy (according surgeon judgement)

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Bordeaux	Bordeaux
France	CHU Caen	Caen
France	CHU Henri Mondor - APHP	Créteil
France	CHU Grenoble	La Tronche
France	Centre Oscar Lambret	Lille
France	CHRU Lille	Lille
France	CHU Limoges	Limoges
France	HCL Lyon	Lyon
France	CH St Joseph	Paris
France	CHU Kremlin Bicêtre - APHP	Paris
France	Hôpital Bichat -APHP	Paris
France	Hôpital Européen Georges Pompidou - APHP	Paris
France	Hôpital Pitié Salpétrière - APHP	Paris
France	Hôpital Tenon - APHP	Paris
France	CHU Poitiers	Poitiers
France	CHU Reims	Reims
France	CHU Rennes - Centre Eugène Marquis	Rennes
France	CHU Rouen	Rouen
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse - Centre Claudius Régaud	Toulouse
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the rates of complications between radical nephrectomy and partial nephrectomy	Operative time, ,	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Primary	Comparison of the rates of complications between radical nephrectomy and partial nephrectomy	Blood loss	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Primary	Comparison of the rates of complications between radical nephrectomy and partial nephrectomy	Clinical scores	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Dosage of creatininemia to assess the renal function after surgery	Dosage of creatininemia	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Dosage of MDRD GFR to assess the renal function after surgery	Dosage of MDRD GFR	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy	Medical or surgical complication rates with Clavien's grading	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy	Medical or surgical complication rates with urinary fistula rate	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy	Medical or surgical complication rates with necessity for nephrectomy or re-exploration	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Safety and efficacy of medical treatment on kidney tumor size evolution	Imaging data: tumor size evolution	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Safety and efficacy of medical treatment on biological parameters	Biological parameters	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years
Secondary	Progression of the tumor	Imaging data: tumor location	At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years