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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03293563
Other study ID # CHUBX 2011/38
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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