<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03293563</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2011/38</org_study_id>
    <nct_id>NCT03293563</nct_id>
  </id_info>
  <brief_title>UroCCR Database: French Research Network for Kidney Cancer</brief_title>
  <acronym>UroCCR</acronym>
  <official_title>UroCCR Database: French Research Network for Kidney Cancer (National Multidisciplinary Clinical and Biological Database on Kidney Cancer)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Within the framework for kidney cancer care, with the recent diversification of treatment&#xD;
      modalities of these tumors and the deployment of the concept of multidisciplinary team, it&#xD;
      was considered necessary to adapt the research tools to reality of health-care for patients&#xD;
      with kidney cancer.&#xD;
&#xD;
      UroCCR is the French research network for kidney cancer, funded by the French National Cancer&#xD;
      Institute as part of the call for projects for clinical and biological databases (BCB).&#xD;
      Depending on the case presentation and disease evolution, more than a thousand of different&#xD;
      variables can be recorded. At the same time, biological samples (plasma, urine, healthy and&#xD;
      tumor tissues) are collected.&#xD;
&#xD;
      This database contains a considerable number of information and high added value since it is&#xD;
      the result of multiple expertises that make it not only a multidisciplinary tool but also&#xD;
      multicenter, allowing fundamental, translational and clinical research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The UroCCR database is a national medico-scientific network focused on therapeutic management&#xD;
      and applied research in kidney cancer.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. - Evaluate and compare different surgical approaches in the treatment of kidney cancer,&#xD;
&#xD;
        2. - Evaluate and compare safety/efficacy of different drugs in the treatment of kidney&#xD;
           cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the rates of complications between radical nephrectomy and partial nephrectomy</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Operative time, ,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of the rates of complications between radical nephrectomy and partial nephrectomy</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Blood loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of the rates of complications between radical nephrectomy and partial nephrectomy</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Clinical scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dosage of creatininemia to assess the renal function after surgery</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Dosage of creatininemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of MDRD GFR to assess the renal function after surgery</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Dosage of MDRD GFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Medical or surgical complication rates with Clavien's grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Medical or surgical complication rates with urinary fistula rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the rates of mortality between radical nephrectomy and partial nephrectomy</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Medical or surgical complication rates with necessity for nephrectomy or re-exploration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and efficacy of medical treatment on kidney tumor size evolution</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Imaging data: tumor size evolution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and efficacy of medical treatment on biological parameters</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Biological parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of the tumor</measure>
    <time_frame>At Month 3, Month 6, Month12, and then every year for 5 years and every 2 years for 10 years</time_frame>
    <description>Imaging data: tumor location</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15000</enrollment>
  <condition>Kidney Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Adult patients with kidney cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical nephrectomy versus partial nephrectomy (according surgeon judgement)</intervention_name>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Kidney cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient with kidney cancer&#xD;
&#xD;
          -  Patient with no opposition to collection of its data for the study&#xD;
&#xD;
        Exclusion Criteria: none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Christophe BERNHARD, PHU</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Christophe BERNHARD, PHU</last_name>
    <phone>+33 (0)5 57 82 03 50</phone>
    <email>jean-christophe.bernhard@chu-bordeaux.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pierre BIGOT</last_name>
    <phone>+33 (0)2 41 35 64 94</phone>
    <email>PiBigot@chu-angers.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre BIGOT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Christophe BERNHARD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud DOERFLER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor - APHP</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre INGELS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Alexandre LONG</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine ADENIS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud VILLERS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélien DESCAZEAUD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>HCL Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69002</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe PAPAREL</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Kremlin Bicêtre - APHP</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sébastien PARIER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH St Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin BRENIER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou - APHP</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François AUDENET</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat -APHP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evangelos Xylinas</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié Salpétrière - APHP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Morgan ROUPRET</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon - APHP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier TRAXER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas CHARLES</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Reims</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane LARRE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Rennes - Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karim BENSALAH</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian PFISTER</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hervé LANG</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Centre Claudius Régaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel SOULIE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck BRUYERE</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 12, 2016</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kidney cancer</keyword>
  <keyword>Surgical approaches</keyword>
  <keyword>Medical treatment</keyword>
  <keyword>Multicentric and multidisciplinary network</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293563
org study id: CHUBX 2011/38
nct id: NCT03293563
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: Operative time, ,
measure: 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
description: Blood loss
measure: 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
description: Clinical scores
measure: 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
description: Dosage of creatininemia
measure: 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
description: Dosage of MDRD GFR
measure: 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
description: Medical or surgical complication rates with Clavien's grading
measure: 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
description: Medical or surgical complication rates with urinary fistula rate
measure: 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
description: Medical or surgical complication rates with necessity for nephrectomy or re-exploration
measure: 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
description: Imaging data: tumor size evolution
measure: 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
description: Biological parameters
measure: 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
description: Imaging data: tumor location
arm group label: Patients
description: Adult patients with kidney cancer
intervention type: Procedure
intervention name: Radical nephrectomy versus partial nephrectomy (according surgeon judgement)
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Christophe BERNHARD, PHU
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Jean-Christophe BERNHARD, PHU
phone: +33 (0)5 57 82 03 50
email: jean-christophe.bernhard@chu-bordeaux.fr
last name: Pierre BIGOT
phone: +33 (0)2 41 35 64 94
email: PiBigot@chu-angers.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell
sharing ipd: No