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/NCT05969964</url>
    </required_header>
    <id_info>
      <org_study_id>MS.23.06.2435</org_study_id>
      <nct_id>NCT05969964</nct_id>
    </id_info>
    <brief_title>Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins</brief_title>
    <official_title>Can Second Resection for pT1 Bladder Carcinoma be Safely Avoided After Initial En-Bloc Resection With Negative Vertical and Horizontal Safety Margins: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</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 goal of this [ Can second resection for pT1 bladder carcinoma be safely avoided after&#xD;
        initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess&#xD;
        the impact of avoiding re TUR on Recurrence free survival, progression free survival and&#xD;
        cancer specific survival in patients with pT1 bladder cancer treated with ERBT and&#xD;
        intravesical BCG through a RCT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bladder cancer (BC) is the one of the most prevalent cancer in Egypt representing nearly 30%&#xD;
        of all cancers. Approximately 75% of newly diagnosed BC present with non-muscle invasive&#xD;
        disease (NMIBC). Initial treatment for most BCs includes transurethral resection (TUR) of the&#xD;
        tumor to obtain tissues sufficient for histo-pathological examination to determine if the&#xD;
        tumor reaches the muscular proprietary or not.&#xD;
  &#xD;
        In the setting of non muscle invasive urothelial carcinoma (NMIBC) especially T1HG, several&#xD;
        studies showed a benefit of performing repeat resection within 2- 6 weeks to ensure adequate&#xD;
        resection and exclude invasion of muscle layer.&#xD;
  &#xD;
        However, several issues make this recommendation ie. Re-TUR at least debatable . First, most&#xD;
        of these recommendations are based on heterogenous studies that didn't report cancer specific&#xD;
        survival (CSS). The risk of upstaging to muscle-invasive disease at re-TUR i did not exceed&#xD;
        7% in recent series . Moreover, the potential complications of re TUR that include bladder&#xD;
        perforation and extravasation may delay administration of intravesical BCG and this delay is&#xD;
        associated with increased risk of tumor recurrence and progression.&#xD;
  &#xD;
        On the other hand, several studies have demonstrated that presence of detrusor muscle (DM) in&#xD;
        the initial specimen is a surrogate marker of resection quality and was associated with less&#xD;
        incidence of residual tumor at the re TUR. New techniques like En-bloc resection of bladder&#xD;
        tumour (ERBT) entails a circumferential incision around the tumor with 5-10 mm safety margin,&#xD;
        then proceed to deep muscle layer underneath the tumor where it is dissected using a&#xD;
        combination of blunt dissection and laser or diathermy energy. This technique allows accurate&#xD;
        assessment of the depth of invasion and the infiltration pattern of NMIBC and thus improving&#xD;
        the accuracy of pathological diagnosis.&#xD;
  &#xD;
        Recently published articles on this topic reported a higher rate of detrusor muscle in the&#xD;
        specimen (96%) with enbloc compared to conventional TURB.&#xD;
  &#xD;
        In a retrospective analysis of 106 patients with pT1 bladder cancer treated with ERBT, 50&#xD;
        patients underwent re-TUR and no significant benefits in terms of RFS and PFS to performing a&#xD;
        reTUR in all patients with pT1 on initial ERBT.&#xD;
  &#xD;
        Residual tumors were found in 6 patients (12%) and none of them were upstaged to T2 disease.&#xD;
        Interestingly, no residual disease or recurrence overtime at the initial ERBT site in&#xD;
        patients with negative horizontal safety margins and residual tumor was found in 2 out of 45&#xD;
        patients with negative vertical safety margins&#xD;
  &#xD;
        Aim of Work&#xD;
  &#xD;
        The aim of this study is to assess the impact of avoiding re TUR after initial enbloc&#xD;
        resection of primary tumor with negative safety margins on recurrence free survival (RFS)&#xD;
        ,progression free survival (PFR) and cancer specific survival (CSS ) in patients with pT1&#xD;
        bladder cancer through a RCT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>Impact of avoiding repeat resection on recurrence and progression free survival.</measure>
      <time_frame>12 month</time_frame>
      <description>occurrence of new tumors or progression of the primary tumor will be compared between both groups. Tis will be assessed by both cystoscopy and MRI findings</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>perioperative complications associated with re TURBT</measure>
      <time_frame>12 month</time_frame>
      <description>The incidence of perioperative complications after repeat resection will be documented and compared between both groups. This outcome will be assessed using Dindo-Clavien classification.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The financial cost associated with performing repeat resection.</measure>
      <time_frame>12 months</time_frame>
      <description>Financial cost of repeat resection will be assessed in USD and compared between both groups.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">370</enrollment>
    <condition>Bladder Cancer Stage I</condition>
    <arm_group>
      <arm_group_label>Re_TUR</arm_group_label>
      <description>Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins will undergo second look as endorsed by the guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No re_TUR</arm_group_label>
      <description>Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines and will receive directly intravesical BCG</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Avoid second resection after initial complete resection</intervention_name>
      <description>Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines.</description>
      <arm_group_label>No re_TUR</arm_group_label>
      <arm_group_label>Re_TUR</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Bladder tumor tissues resected during cystoscopy&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Male and female patients treated with ERBT and diagnosed with pT1 disease with negative&#xD;
          vertical and horizontal safety margins at final pathology.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and&#xD;
          horizontal safety margins at final pathology.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Large tumors not suitable for ERBT&#xD;
  &#xD;
            -  Residual tumor.&#xD;
  &#xD;
            -  Multicentric tumors ( more than 4 lesions)&#xD;
  &#xD;
            -  Presence of CIS.&#xD;
  &#xD;
            -  Positive vertical or horizontal safety margins after initial resection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mahmoud Laymon, MD,MRCS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Urology &amp;Nephrology Center, Mansoura University, Egypt</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mahmoud Laymon, MD,MRCS</last_name>
      <phone>01002275698</phone>
      <email>dr_mahmoudlaymon@mans.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmed elassmy, MD</last_name>
      <email>a_assmy@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Urology and nephrology center, Mansoura University</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahlia</state>
          <zip>35516</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmed Mosbah, MD</last_name>
        <phone>01002275698</phone>
        <email>mosbah64@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05969964
  org study id: MS.23.06.2435
  nct id: NCT05969964
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this [ Can second resection for pT1 bladder carcinoma be safely avoided after
        initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess
        the impact of avoiding re TUR on Recurrence free survival, progression free survival and
        cancer specific survival in patients with pT1 bladder cancer treated with ERBT and
        intravesical BCG through a RCT.
  Bladder cancer (BC) is the one of the most prevalent cancer in Egypt representing nearly 30%
        of all cancers. Approximately 75% of newly diagnosed BC present with non-muscle invasive
        disease (NMIBC). Initial treatment for most BCs includes transurethral resection (TUR) of the
        tumor to obtain tissues sufficient for histo-pathological examination to determine if the
        tumor reaches the muscular proprietary or not.
  
        In the setting of non muscle invasive urothelial carcinoma (NMIBC) especially T1HG, several
        studies showed a benefit of performing repeat resection within 2- 6 weeks to ensure adequate
        resection and exclude invasion of muscle layer.
  
        However, several issues make this recommendation ie. Re-TUR at least debatable . First, most
        of these recommendations are based on heterogenous studies that didn't report cancer specific
        survival (CSS). The risk of upstaging to muscle-invasive disease at re-TUR i did not exceed
        7% in recent series . Moreover, the potential complications of re TUR that include bladder
        perforation and extravasation may delay administration of intravesical BCG and this delay is
        associated with increased risk of tumor recurrence and progression.
  
        On the other hand, several studies have demonstrated that presence of detrusor muscle (DM) in
        the initial specimen is a surrogate marker of resection quality and was associated with less
        incidence of residual tumor at the re TUR. New techniques like En-bloc resection of bladder
        tumour (ERBT) entails a circumferential incision around the tumor with 5-10 mm safety margin,
        then proceed to deep muscle layer underneath the tumor where it is dissected using a
        combination of blunt dissection and laser or diathermy energy. This technique allows accurate
        assessment of the depth of invasion and the infiltration pattern of NMIBC and thus improving
        the accuracy of pathological diagnosis.
  
        Recently published articles on this topic reported a higher rate of detrusor muscle in the
        specimen (96%) with enbloc compared to conventional TURB.
  
        In a retrospective analysis of 106 patients with pT1 bladder cancer treated with ERBT, 50
        patients underwent re-TUR and no significant benefits in terms of RFS and PFS to performing a
        reTUR in all patients with pT1 on initial ERBT.
  
        Residual tumors were found in 6 patients (12%) and none of them were upstaged to T2 disease.
        Interestingly, no residual disease or recurrence overtime at the initial ERBT site in
        patients with negative horizontal safety margins and residual tumor was found in 2 out of 45
        patients with negative vertical safety margins
  
        Aim of Work
  
        The aim of this study is to assess the impact of avoiding re TUR after initial enbloc
        resection of primary tumor with negative safety margins on recurrence free survival (RFS)
        ,progression free survival (PFR) and cancer specific survival (CSS ) in patients with pT1
        bladder cancer through a RCT.
  observational model: Case-Control
  time perspective: Prospective
  measure: Impact of avoiding repeat resection on recurrence and progression free survival.
  time frame: 12 month
  description: occurrence of new tumors or progression of the primary tumor will be compared between both groups. Tis will be assessed by both cystoscopy and MRI findings
  measure: perioperative complications associated with re TURBT
  time frame: 12 month
  description: The incidence of perioperative complications after repeat resection will be documented and compared between both groups. This outcome will be assessed using Dindo-Clavien classification.
  measure: The financial cost associated with performing repeat resection.
  time frame: 12 months
  description: Financial cost of repeat resection will be assessed in USD and compared between both groups.
  arm group label: Re_TUR
  description: Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins will undergo second look as endorsed by the guidelines.
  arm group label: No re_TUR
  description: Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines and will receive directly intravesical BCG
  intervention type: Behavioral
  intervention name: Avoid second resection after initial complete resection
  description: Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines.
  arm group label: No re_TUR
  arm group label: Re_TUR
  Bladder tumor tissues resected during cystoscopy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Mahmoud Laymon, MD,MRCS
  role: Principal Investigator
  affiliation: Urology &Nephrology Center, Mansoura University, Egypt
  last name: Mahmoud Laymon, MD,MRCS
  phone: 01002275698
  email: dr_mahmoudlaymon@mans.edu.eg
  last name: Ahmed elassmy, MD
  email: a_assmy@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: Undecided