UroCCR Database: French Research Network for Kidney Cancer (UroCCR)
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| ClinicalTrials.gov Identifier: NCT03293563 |
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Recruitment Status :
Recruiting
First Posted : September 26, 2017
Last Update Posted : November 8, 2022
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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) |
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 Type : | Observational |
| Estimated Enrollment : | 15000 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 2024 |
| Estimated Study Completion Date : | December 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients
Adult patients with kidney cancer
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Procedure: Radical nephrectomy versus partial nephrectomy (according surgeon judgement) |
- 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, ,
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 |
Inclusion Criteria:
- Adult patient with kidney cancer
- Patient with no opposition to collection of its data for the study
Exclusion Criteria: none
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
| 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 |
Show 22 study locations
| Principal Investigator: | Jean-Christophe BERNHARD, PHU | University Hospital, Bordeaux |
| 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: | November 8, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Kidney cancer Surgical approaches Medical treatment Multicentric and multidisciplinary network |
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Kidney Neoplasms Carcinoma, Renal Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Kidney Diseases Urologic Diseases Male Urogenital Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |