<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/NCT04503577</url>
  </required_header>
  <id_info>
    <org_study_id>ProBCI</org_study_id>
    <nct_id>NCT04503577</nct_id>
  </id_info>
  <brief_title>Prospective Bladder Cancer Infrastructure (ProBCI)</brief_title>
  <acronym>ProBCI</acronym>
  <official_title>Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prospective Bladder Cancer Infrastructure Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prospective Bladder Cancer Infrastructure Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and&#xD;
      metastatic bladder cancer in the Netherlands&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 4, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2041</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2040</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>20 Years</target_duration>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>10 years</time_frame>
    <description>Alive/death/emigrated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>10 yeas</time_frame>
    <description>Progression/no progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival</measure>
    <time_frame>10 yeas</time_frame>
    <description>Recurrence/no recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>EQ-5D (EuroQol-Five Dimensions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific health-related quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>QLQ-C30 (Quality of Life Questionnaire-Cancer)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3600</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Bladder cancer patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Bladder cancer patients with high-risk non-muscle-invasive bladder cancer (T1, Tis or&#xD;
        Ta+cis), muscle-invasvie bladder cancer (T2-4, any N, M0/X), and metastatic bladder cancer&#xD;
        (any T, any N, M1a/b)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bladder cancer&#xD;
&#xD;
          -  Any stage except Ta&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
&#xD;
        Note: participation in ProBCI does not exclude the patient from participation in other&#xD;
        studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>A. Richters, PhD</last_name>
    <phone>0031623237842</phone>
    <email>a.richters@iknl.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jeroen Bosch Hospital</name>
      <address>
        <city>'s-Hertogenbosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Meander Medical Center</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Radboud univerisity Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bladder cancer</keyword>
  <keyword>Prospective cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual patient data are available upon request to other research groups (please see www.probci.nl for procedure).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_url>http://www.probci.nl</ipd_url>
  </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/NCT04503577
org study id: ProBCI
nct id: NCT04503577
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and
      metastatic bladder cancer in the Netherlands
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: 10 years
description: Alive/death/emigrated
measure: Progression-free survival
time frame: 10 yeas
description: Progression/no progression
measure: Recurrence-free survival
time frame: 10 yeas
description: Recurrence/no recurrence
measure: Health-related quality of life
time frame: 2 years
description: EQ-5D (EuroQol-Five Dimensions)
measure: Cancer-specific health-related quality of life
time frame: 2 years
description: QLQ-C30 (Quality of Life Questionnaire-Cancer)
arm group label: Bladder cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: A. Richters, PhD
phone: 0031623237842
email: a.richters@iknl.nl
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Netherlands
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
sharing ipd: Yes
ipd description: Individual patient data are available upon request to other research groups (please see www.probci.nl for procedure).
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd url: http://www.probci.nl