xml: <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/NCT06020807</url>
    </required_header>
    <id_info>
      <org_study_id>UC-Bladder EpiCheck-FDA-02</org_study_id>
      <nct_id>NCT06020807</nct_id>
    </id_info>
    <brief_title>Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer</brief_title>
    <official_title>Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nucleix Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nucleix Ltd.</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>
        This is a prospective study to establish the analytical specificity of Bladder EpiCheck test&#xD;
        in urine samples from healthy population and urology patients without prior history or&#xD;
        evidence of bladder cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 5, 2019</start_date>
    <completion_date type="Actual">January 8, 2020</completion_date>
    <primary_completion_date type="Actual">January 8, 2020</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>Specificity</measure>
      <time_frame>Day 1</time_frame>
      <description>The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">168</enrollment>
    <condition>Non Muscle Invasive Bladder Cancer</condition>
    <condition>Non-Muscle Invasive Bladder Urothelial Carcinoma</condition>
    <arm_group>
      <arm_group_label>Healthy</arm_group_label>
      <description>Healthy subjects and urology patients without prior history or evidence of bladder cancer</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Bladder EpiCheck</intervention_name>
      <description>Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.</description>
      <arm_group_label>Healthy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy subjects and urology patients without prior history or evidence of bladder cancer&#xD;
          will be recruited from urology group clinics.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 22 or older&#xD;
  &#xD;
            -  Able to sign the informed consent form&#xD;
  &#xD;
            -  Normal, healthy subjects or subjects with one of the following conditions:&#xD;
  &#xD;
                 1. Benign non-genitourinary disease (e.g. heart disease)&#xD;
  &#xD;
                 2. Non-genitourinary cancers (e.g. lung, CRC, breast)&#xD;
  &#xD;
                 3. Genitourinary disease other than bladder cancer including:&#xD;
  &#xD;
                 4. Benign prostatic hyperplasia (BPH)&#xD;
  &#xD;
                 5. Microhematuria proven negative for bladder cancer through prior UCC evaluation&#xD;
  &#xD;
                 6. Inflammation/infection&#xD;
  &#xD;
                 7. Symptomatic sexually transmitted disease (STD)&#xD;
  &#xD;
                 8. Urinary tract stones&#xD;
  &#xD;
                 9. Genitourinary trauma&#xD;
  &#xD;
            -  Subjects with native bladder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)&#xD;
  &#xD;
            -  Currently in work-up due to suspicion of cancer of any kind&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Urology San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020807
  org study id: UC-Bladder EpiCheck-FDA-02
  nct id: NCT06020807
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective study to establish the analytical specificity of Bladder EpiCheck test
        in urine samples from healthy population and urology patients without prior history or
        evidence of bladder cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: Specificity
  time frame: Day 1
  description: The primary endpoint of the study is the specificity of the Bladder EpiCheck Test in healthy population.
  arm group label: Healthy
  description: Healthy subjects and urology patients without prior history or evidence of bladder cancer
  intervention type: Diagnostic Test
  intervention name: Bladder EpiCheck
  description: Bladder EpiCheckTM (EpiCheck) is a urine test for monitoring of recurrence of NMIBC based on analysis of 15 informative DNA methylation biomarkers.
  arm group label: Healthy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  mesh term: Non-Muscle Invasive Bladder Neoplasms
  sharing ipd: No