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/NCT05979909</url>
    </required_header>
    <id_info>
      <org_study_id>14728</org_study_id>
      <nct_id>NCT05979909</nct_id>
    </id_info>
    <brief_title>Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma</brief_title>
    <official_title>Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McMaster University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>McMaster University</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>
        The objective of this pilot study is to determine the feasibility of conducting a phase III&#xD;
        randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence&#xD;
        (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In&#xD;
        the current study, 40 patients will be randomized to receive MMC or no intervention and will&#xD;
        be followed for two years to determine the incidence of adverse events and IVR.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>30 days</time_frame>
      <description>Proportion of patients who consent to participate in the study after being invited to do so</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Randomization rate</measure>
      <time_frame>30 days</time_frame>
      <description>Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention rate</measure>
      <time_frame>2 years</time_frame>
      <description>Proportion of randomized patients who complete follow-up</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse events (any)</measure>
      <time_frame>30 days</time_frame>
      <description>Cumulative incidence of adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events (severe)</measure>
      <time_frame>30 days</time_frame>
      <description>Cumulative incidence of grade 3-5 adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intravesical recurrence</measure>
      <time_frame>2 years</time_frame>
      <description>Cumulative incidence of urothelial carcinoma of the bladder</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Urothelial Carcinoma Ureter</condition>
    <condition>Urothelial Cancer of Renal Pelvis</condition>
    <arm_group>
      <arm_group_label>Intravesical mitomycin C (MMC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>No intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mitomycin C</intervention_name>
      <description>Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.</description>
      <arm_group_label>Intravesical mitomycin C (MMC)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Suspected upper tract urothelial carcinoma (UTUC)&#xD;
  &#xD;
            -  Diagnostic ureteroscopy required&#xD;
  &#xD;
            -  Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior or concomitant urothelial carcinoma of the bladder&#xD;
  &#xD;
            -  History of UTUC&#xD;
  &#xD;
            -  Ureteroscopy within the preceding six months&#xD;
  &#xD;
            -  Untreated urinary tract infection&#xD;
  &#xD;
            -  Suspected or confirmed perforation of the upper or lower urinary tract&#xD;
  &#xD;
            -  Lower urinary tract fistula&#xD;
  &#xD;
            -  Leukopenia or thrombocytopenia&#xD;
  &#xD;
            -  ECOG performance status 2 or greater&#xD;
  &#xD;
            -  Known hypersensitivity to mitomycin C&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Lack of capacity to 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>
    <overall_contact>
      <last_name>Piotr Zareba, MD MPH</last_name>
      <phone>(905) 521-2100</phone>
      <phone_ext>47109</phone_ext>
      <email>zareba@hhsc.ca</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 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>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Transitional Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitomycins</mesh_term>
      <mesh_term>Mitomycin</mesh_term>
    </intervention_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/NCT05979909
  org study id: 14728
  nct id: NCT05979909
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this pilot study is to determine the feasibility of conducting a phase III
        randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence
        (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In
        the current study, 40 patients will be randomized to receive MMC or no intervention and will
        be followed for two years to determine the incidence of adverse events and IVR.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Recruitment rate
  time frame: 30 days
  description: Proportion of patients who consent to participate in the study after being invited to do so
  measure: Randomization rate
  time frame: 30 days
  description: Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
  measure: Retention rate
  time frame: 2 years
  description: Proportion of randomized patients who complete follow-up
  measure: Adverse events (any)
  time frame: 30 days
  description: Cumulative incidence of adverse events
  measure: Adverse events (severe)
  time frame: 30 days
  description: Cumulative incidence of grade 3-5 adverse events
  measure: Intravesical recurrence
  time frame: 2 years
  description: Cumulative incidence of urothelial carcinoma of the bladder
  arm group label: Intravesical mitomycin C (MMC)
  arm group type: Experimental
  arm group label: No intervention
  arm group type: No Intervention
  intervention type: Drug
  intervention name: Mitomycin C
  description: Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.
  arm group label: Intravesical mitomycin C (MMC)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Piotr Zareba, MD MPH
  phone: (905) 521-2100
  phone ext: 47109
  email: zareba@hhsc.ca
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Transitional Cell
  mesh term: Mitomycins
  mesh term: Mitomycin
  sharing ipd: No