<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/NCT03796299</url>
  </required_header>
  <id_info>
    <org_study_id>4-2018</org_study_id>
    <nct_id>NCT03796299</nct_id>
  </id_info>
  <brief_title>Expression of MCM5 in Urine in Patients With Urothelial Cancers</brief_title>
  <official_title>Expression of MCM5 in Urine in Patients With Urothelial Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with non-muscle-invasive bladder cancer, the development and introduction to the&#xD;
      clinical practice of an adequately accurate biomarker may allow to limit the indications for&#xD;
      performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients,&#xD;
      the risk of complications of the invasive procedure and probably significantly reduce the&#xD;
      costs incurred by healthcare systems.&#xD;
&#xD;
      The aim of the present study is to determine the usefulness of the determination of MCM5&#xD;
      protein expression in the urine of patients with urinary bladder or upper urinary tract&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Expression of MCM-5 in the urine</measure>
    <time_frame>Within 48 hours after subject enrollment</time_frame>
    <description>Expression of MCM-5 will be determined in urine sediment by Arquer Diagnostics ADXBLADDER test (ELISA test using two monoclonal antibodies directed against epitopes of high affinity and specificity for the MCM5 antigen).</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Patients with bladder cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>Patients with upper urinary tract cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 (control)</arm_group_label>
    <description>Controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Assessment of expression of MCM5 in the urine (ADX Bladder)</intervention_name>
    <description>Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3 (control)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients qualified for surgery due to bladder or upper urinary tract tumors and controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years,&#xD;
&#xD;
          -  written consent to participate in the study,&#xD;
&#xD;
          -  ability to void and collect &gt;50ml of urine,&#xD;
&#xD;
          -  recurrent bladder cancer confirmed by cystoscopy (group 1) or upper urinary tract&#xD;
             tumor confirmed by imaging studies (group 2) or no history of urological/gynecological&#xD;
             cancers (controls)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  urinary tracy infection,&#xD;
&#xD;
          -  nephrolithiasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Warsaw, Dept. of Urology</name>
      <address>
        <city>Warsaw</city>
        <zip>02005</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bladder cancer</keyword>
  <keyword>biomarker</keyword>
  <keyword>urothelial cancer</keyword>
  <keyword>cystoscopy</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>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/NCT03796299
org study id: 4-2018
nct id: NCT03796299
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In patients with non-muscle-invasive bladder cancer, the development and introduction to the
      clinical practice of an adequately accurate biomarker may allow to limit the indications for
      performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients,
      the risk of complications of the invasive procedure and probably significantly reduce the
      costs incurred by healthcare systems.

      The aim of the present study is to determine the usefulness of the determination of MCM5
      protein expression in the urine of patients with urinary bladder or upper urinary tract
      cancer.
observational model: Case-Control
time perspective: Prospective
measure: Expression of MCM-5 in the urine
time frame: Within 48 hours after subject enrollment
description: Expression of MCM-5 will be determined in urine sediment by Arquer Diagnostics ADXBLADDER test (ELISA test using two monoclonal antibodies directed against epitopes of high affinity and specificity for the MCM5 antigen).
arm group label: 1
description: Patients with bladder cancer
arm group label: 2
description: Patients with upper urinary tract cancer
arm group label: 3 (control)
description: Controls
intervention type: Diagnostic Test
intervention name: Assessment of expression of MCM5 in the urine (ADX Bladder)
description: Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen.
arm group label: 1
arm group label: 2
arm group label: 3 (control)
Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
sharing ipd: No