<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/NCT02969109</url>
  </required_header>
  <id_info>
    <org_study_id>14-006</org_study_id>
    <nct_id>NCT02969109</nct_id>
  </id_info>
  <brief_title>Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer</brief_title>
  <official_title>Clinical Validation of a Urine-based Assay With Genomic and Epigenomic Markers for Predicting Recurrence During Surveillance for Non-muscle Invasive Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genomic Health®, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genomic Health®, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to validate, in a prospective manner, the ability of the predefined Genomic Health&#xD;
      bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle&#xD;
      invasive bladder cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">September 18, 2018</completion_date>
  <primary_completion_date type="Actual">September 18, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The recurrence status based on the pathology results</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The Genomic Health bladder cancer assay results.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">417</enrollment>
  <condition>Non-muscle Invasive Bladder Cancer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine and tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Non-muscle invasive bladder cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma&#xD;
             of the bladder scheduled to undergo surveillance cystoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years&#xD;
&#xD;
          -  Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell&#xD;
             carcinoma of the bladder&#xD;
&#xD;
          -  Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2&#xD;
             or greater)&#xD;
&#xD;
          -  Patients who are unable or unwilling to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute for Prostate and Urologic Cancers - University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
    <mesh_term>Recurrence</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/NCT02969109
org study id: 14-006
nct id: NCT02969109
lead sponsor: 
has dmc: No
A study to validate, in a prospective manner, the ability of the predefined Genomic Health
      bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle
      invasive bladder cancer.
observational model: Other
time perspective: Prospective
measure: The recurrence status based on the pathology results
time frame: 1 year
measure: The Genomic Health bladder cancer assay results.
time frame: 1 year
Urine and tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
mesh term: Recurrence
sharing ipd: No