UroCCR Database: French Research Network for Kidney Cancer

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT03293563

Collaborator

(none)

12,000

Enrollment

Locations

120

Duration (Months)

571.4

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Procedure: Radical nephrectomy versus partial nephrectomy (according surgeon judgement)

Detailed Description

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

Secondary objectives:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

12000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients Adult patients with kidney cancer	Procedure: Radical nephrectomy versus partial nephrectomy (according surgeon judgement)

Arm

Intervention/Treatment

Patients

Adult patients with kidney cancer

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

Outcome Measures

Primary Outcome Measures

Comparison of the rates of complications between radical nephrectomy and partial nephrectomy [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Operative time, ,
Comparison of the rates of complications between radical nephrectomy and partial nephrectomy [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Blood loss
Comparison of the rates of complications between radical nephrectomy and partial nephrectomy [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Clinical scores

Secondary Outcome Measures

Dosage of creatininemia to assess the renal function after surgery [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Dosage of creatininemia
Dosage of MDRD GFR to assess the renal function after surgery [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Dosage of MDRD GFR
Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Medical or surgical complication rates with Clavien's grading
Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Medical or surgical complication rates with urinary fistula rate
Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Medical or surgical complication rates with necessity for nephrectomy or re-exploration
Safety and efficacy of medical treatment on kidney tumor size evolution [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Imaging data: tumor size evolution
Safety and efficacy of medical treatment on biological parameters [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Biological parameters
Progression of the tumor [At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years]
Imaging data: tumor location

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patient with kidney cancer
Patient with no opposition to collection of its data for the study

Exclusion Criteria: none

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Angers	Angers	France	49100
2	CHU Bordeaux	Bordeaux	France	33076
3	CHU Caen	Caen	France
4	CHU Henri Mondor - APHP	Créteil	France	94010
5	CHU Grenoble	La Tronche	France	38700
6	Centre Oscar Lambret	Lille	France	59020
7	CHRU Lille	Lille	France	59037
8	CHU Limoges	Limoges	France	87042
9	HCL Lyon	Lyon	France	69002
10	CHU Kremlin Bicêtre - APHP	Paris	France	75013
11	CH St Joseph	Paris	France	75014
12	Hôpital Européen Georges Pompidou - APHP	Paris	France	75015
13	Hôpital Bichat -APHP	Paris	France
14	Hôpital Pitié Salpétrière - APHP	Paris	France
15	CHU Poitiers	Poitiers	France
16	CHU Reims	Reims	France
17	CHU Rennes - Centre Eugène Marquis	Rennes	France	35000
18	CHU Rouen	Rouen	France	76031
19	CHU Strasbourg	Strasbourg	France	67000
20	CHU Toulouse - Centre Claudius Régaud	Toulouse	France	31059
21	CHRU Tours	Tours	France