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UroCCR Database: French Research Network for Kidney Cancer (UroCCR)

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ClinicalTrials.gov Identifier: NCT03293563
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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
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:

  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.

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Study Type : Observational
Estimated Enrollment : 9600 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 : December 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Group/Cohort Intervention/treatment
Patients
Adult patients with kidney cancer
Procedure: Radical nephrectomy versus partial nephrectomy (according surgeon judgement)



Primary Outcome Measures :
  1. Comparison of the rates of complications between radical nephrectomy and partial nephrectomy [ Time Frame: At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years ]
    Operative time, ,

  2. Comparison of the rates of complications between radical nephrectomy and partial nephrectomy [ Time Frame: At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years ]
    Blood loss

  3. Comparison of the rates of complications between radical nephrectomy and partial nephrectomy [ Time Frame: 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 :
  1. Dosage of creatininemia to assess the renal function after surgery [ Time Frame: At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years ]
    Dosage of creatininemia

  2. Dosage of MDRD GFR to assess the renal function after surgery [ Time Frame: At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years ]
    Dosage of MDRD GFR

  3. Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy [ Time Frame: 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

  4. Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy [ Time Frame: 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

  5. Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy [ Time Frame: 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

  6. Safety and efficacy of medical treatment on kidney tumor size evolution [ Time Frame: 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

  7. Safety and efficacy of medical treatment on biological parameters [ Time Frame: At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years ]
    Biological parameters

  8. Progression of the tumor [ Time Frame: At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years ]
    Imaging data: tumor location



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Kidney cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria: none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293563


Contacts
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Contact: Jean-Christophe BERNHARD, PHU +33 (0)5 57 82 03 50 jean-christophe.bernhard@chu-bordeaux.fr
Contact: Pierre BIGOT +33 (0)2 41 35 64 94 PiBigot@chu-angers.fr

Locations
Show Show 21 study locations
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Jean-Christophe BERNHARD, PHU University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03293563    
Other Study ID Numbers: CHUBX 2011/38
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Bordeaux:
Kidney cancer
Surgical approaches
Medical treatment
Multicentric and multidisciplinary network
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type