<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/NCT03839472</url>
  </required_header>
  <id_info>
    <org_study_id>CASE12818</org_study_id>
    <nct_id>NCT03839472</nct_id>
  </id_info>
  <brief_title>Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors</brief_title>
  <official_title>Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this pilot study is to determine if washing out the bladder with large volumes&#xD;
      of saline after surgical removal of bladder tumors helps to decrease the number of loose&#xD;
      cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence&#xD;
      and/or progression rates will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs&#xD;
      in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a&#xD;
      single-arm, non-randomized pilot study looking to determine whether post-Transurethral&#xD;
      Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous&#xD;
      washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated&#xD;
      decrease in tumor recurrence and/or progression rates will also be measured, and each&#xD;
      participant will act as their own internal control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Revision to improve cell recovery&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single arm where each patient will act as his/her own internal control (cell count before and after CBI).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean cells count before versus after liter 1 of CBI</measure>
    <time_frame>Immediately after CBI procedure.</time_frame>
    <description>The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean cells count before versus after liter 2 of CBI</measure>
    <time_frame>Immediately after CBI procedure.</time_frame>
    <description>The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean cells count before versus after liter 3 of CBI</measure>
    <time_frame>Immediately after CBI procedure.</time_frame>
    <description>The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean cells count before versus after liter 4 of CBI</measure>
    <time_frame>Immediately after CBI procedure.</time_frame>
    <description>The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean cells count before versus after liter 5 of CBI</measure>
    <time_frame>Immediately after CBI procedure.</time_frame>
    <description>The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate of patients who underwent CBI post TURBT.</measure>
    <time_frame>2 years after end of treatment</time_frame>
    <description>Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.&#xD;
Recurrence is defined as the identification of a recurrent tumor of same grade and or stage or lower</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression rate of patients who underwent CBI post TURBT.</measure>
    <time_frame>2 years after end of treatment</time_frame>
    <description>Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.&#xD;
Progression is defined as a recurrent tumor of higher grade and or stage</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-muscle Invasive Bladder Cancer (NMIBC)</condition>
  <condition>Bladder Tumor (TURBT)</condition>
  <arm_group>
    <arm_group_label>Continuous Bladder Irrigation (CBI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure.&#xD;
Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CBI</intervention_name>
    <description>CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.</description>
    <arm_group_label>Continuous Bladder Irrigation (CBI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging&#xD;
             study&#xD;
&#xD;
          -  Primary bladder tumor occurrence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with unresectable bladder tumors, as determined at the time of diagnosis or&#xD;
             TURBT , or imaging concerning of T2 or higher disease&#xD;
&#xD;
          -  Patients with bladder perforation at the time of TURBT, which is a contraindication to&#xD;
             CBI&#xD;
&#xD;
          -  Patients from vulnerable populations, including but not limited to impaired subjects,&#xD;
             pregnant women, prisoners, family members of the study team&#xD;
&#xD;
          -  Any previous history of bladder tumor resection or intravesical&#xD;
             chemotherapy/immunotherapy&#xD;
&#xD;
          -  History of previous pelvic radiation&#xD;
&#xD;
          -  Bladder tumor volume &gt; 5 cm, involvement of prostatic urethra, or any evidence of&#xD;
             hydronephrosis on imaging&#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_official>
    <last_name>Lee Ponsky</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</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>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication</ipd_time_frame>
    <ipd_access_criteria>To be shared with investigators whose proposed use of the data has been approved by an independent review committee (&quot;learned intermediary&quot;) identified for this purpose. For individual participant data meta-analysis.</ipd_access_criteria>
  </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/NCT03839472
org study id: CASE12818
nct id: NCT03839472
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to determine if washing out the bladder with large volumes
      of saline after surgical removal of bladder tumors helps to decrease the number of loose
      cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence
      and/or progression rates will be measured.
Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs
      in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a
      single-arm, non-randomized pilot study looking to determine whether post-Transurethral
      Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous
      washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated
      decrease in tumor recurrence and/or progression rates will also be measured, and each
      participant will act as their own internal control.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm where each patient will act as his/her own internal control (cell count before and after CBI).
primary purpose: Treatment
masking: None (Open Label)
measure: Change in mean cells count before versus after liter 1 of CBI
time frame: Immediately after CBI procedure.
description: The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
measure: Change in mean cells count before versus after liter 2 of CBI
time frame: Immediately after CBI procedure.
description: The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
measure: Change in mean cells count before versus after liter 3 of CBI
time frame: Immediately after CBI procedure.
description: The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
measure: Change in mean cells count before versus after liter 4 of CBI
time frame: Immediately after CBI procedure.
description: The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
measure: Change in mean cells count before versus after liter 5 of CBI
time frame: Immediately after CBI procedure.
description: The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
measure: Recurrence rate of patients who underwent CBI post TURBT.
time frame: 2 years after end of treatment
description: Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.
Recurrence is defined as the identification of a recurrent tumor of same grade and or stage or lower
measure: Progression rate of patients who underwent CBI post TURBT.
time frame: 2 years after end of treatment
description: Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.
Progression is defined as a recurrent tumor of higher grade and or stage
arm group label: Continuous Bladder Irrigation (CBI)
arm group type: Experimental
description: Each subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure.
Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples.
intervention type: Procedure
intervention name: CBI
description: CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.
arm group label: Continuous Bladder Irrigation (CBI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lee Ponsky
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication
ipd access criteria: To be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis.