<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/NCT01706185</url>
  </required_header>
  <id_info>
    <org_study_id>111294</org_study_id>
    <nct_id>NCT01706185</nct_id>
  </id_info>
  <brief_title>Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer</brief_title>
  <official_title>Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1,&#xD;
      WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated&#xD;
      bladder cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be no procedure(s) or treatment(s) carried out on patients. All data and samples&#xD;
      will be taken from those already stored at the investigation sites. Clinical data collected&#xD;
      will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system)&#xD;
      [TNM stage], and histopathologic description only. Strict anonymity of patient data will be&#xD;
      maintained.&#xD;
&#xD;
      This retrospective study is based upon the analysis of archived formalin-fixed&#xD;
      paraffin-embedded tissue samples and patient-related data already available at the&#xD;
      investigational site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2008</start_date>
  <completion_date type="Actual">January 15, 2008</completion_date>
  <primary_completion_date type="Actual">January 15, 2008</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">156</enrollment>
  <condition>Neoplasms, Urinary Bladder</condition>
  <arm_group>
    <arm_group_label>Cancer Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data acquisition and analysis</intervention_name>
    <description>Tumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer.</description>
    <arm_group_label>Cancer Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Previously collected samples and data of patients with pathologically demonstrated bladder&#xD;
        cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For inclusion of a tissue sample, all of the following criteria must be met:&#xD;
&#xD;
          -  The patient had pathologically proven bladder cancer (any stage).&#xD;
&#xD;
          -  All the data required are available from patient's records.&#xD;
&#xD;
        There are no restrictions regarding operative technique (cystectomy or cystoscopy).&#xD;
&#xD;
        - Many patients may no longer be alive, or no longer be in contact with the investigation&#xD;
        sites. Thus, patients will not be required to give their informed consent before inclusion&#xD;
        in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patients</keyword>
  <keyword>Tumor antigens</keyword>
  <keyword>Bladder cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01706185
org study id: 111294
nct id: NCT01706185
lead sponsor: 
This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1,
      WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated
      bladder cancer.
There will be no procedure(s) or treatment(s) carried out on patients. All data and samples
      will be taken from those already stored at the investigation sites. Clinical data collected
      will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system)
      [TNM stage], and histopathologic description only. Strict anonymity of patient data will be
      maintained.

      This retrospective study is based upon the analysis of archived formalin-fixed
      paraffin-embedded tissue samples and patient-related data already available at the
      investigational site.
observational model: Cohort
time perspective: Retrospective
measure: To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.
time frame: Up to 1 year
arm group label: Cancer Group
intervention type: Other
intervention name: Data acquisition and analysis
description: Tumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer.
arm group label: Cancer Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms