<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/NCT02992990</url>
  </required_header>
  <id_info>
    <org_study_id>H-40414</org_study_id>
    <nct_id>NCT02992990</nct_id>
  </id_info>
  <brief_title>Bladder Tumor Biopsy Study to Improve Preoperative Determination of Stage and Grade</brief_title>
  <official_title>A Prospective Study To Assess Whether A Preoperative Tumor Biopsy Can Improve Upon The Endoscopic Impression Determination Of Stage And Grade In Non-Muscle-Invasive Urothelial Carcinoma Of The Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</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>
      To assess whether the addition of a bladder tumor biopsy improves the level of agreement&#xD;
      between the pretreatment endoscopic impression and the final postoperative pathology&#xD;
      determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-invasive bladder cancer is challenging to treat because it is a condition characterized&#xD;
      by frequent recurrences that lead to numerous invasive procedures for detection and&#xD;
      treatment. The mainstay of therapy for non-muscle invasive bladder cancer, which has remained&#xD;
      unchanged for decades, relies on surgical resection (TUR) associated with utilization of&#xD;
      intravesical immunotherapy and chemotherapy. Despite our best efforts, these tumors continue&#xD;
      to have suboptimal rates of recurrence and require long-term follow-up with costly and&#xD;
      invasive procedures. The rationale for this study is to show that the preoperative biopsy,&#xD;
      taken at the time of the office cystoscopic evaluation, improves pre-TUR staging and grading&#xD;
      correlation with the final pathology of the resection. Indirectly, this will suggest that the&#xD;
      routine use of pre-TUR biopsy provides more accurate information for intraoperative&#xD;
      decision-making that can ultimately lead to better management of these patients with&#xD;
      non-muscle-invasive bladder cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2023</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors.</measure>
    <time_frame>3 years</time_frame>
    <description>Assessment of grade, which is the main endpoint will be dichotomous defining lesions between low versus high grade. Stage classification of non-muscle-invasive papillary lesions is also dichotomous between Ta and T1 lesions. CIS can be annotated, but since these are flat, diffuse and non &quot;resectable&quot; in the bladder, they are not part of our main analysis, endpoints, or sample size calculations. The only exception is when the presence of CIS is used to determine grade (high-grade lesion).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Bladder tumor biopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All subjects will undergo a bladder tumor biopsy followed by transurethral resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bladder tumor biopsy</intervention_name>
    <description>Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.</description>
    <arm_group_label>Bladder tumor biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or females, age 21 or older;&#xD;
&#xD;
          -  Clinical evidence of urothelial carcinoma of the bladder;&#xD;
&#xD;
          -  Clinically (endoscopic, by physical examination, and/or axial-imaging) deemed&#xD;
             non-muscle-invasive tumor of the bladder (cTis-Ta-T1), of any grade, single or&#xD;
             multiple, at initial occurrence or recurrent with &gt;12 months interval free of disease;&#xD;
&#xD;
          -  Surgically eligible for the TUR;&#xD;
&#xD;
          -  Patient or authorized proxy needs to have signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any muscle-invasive or non-organ confined bladder tumors (T2 or higher);&#xD;
&#xD;
          -  Patients with sessile appearing bladder tumors, which may be T2 or higher stage;&#xD;
&#xD;
          -  Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary&#xD;
             tract;&#xD;
&#xD;
          -  Concurrent use of anticoagulation medication or chronic use of NSAIDs, including&#xD;
             aspirin (other than cardio protective doses of 80mg daily) that has not been&#xD;
             appropriately interrupted before the office cystoscopic evaluation;&#xD;
&#xD;
          -  Patient deemed medically or psychologically unfit for the surgical procedure;&#xD;
&#xD;
          -  Subject has received any investigational medication within 30 days prior to the&#xD;
             registration or is scheduled to receive an investigational drug during the course of&#xD;
             the study;&#xD;
&#xD;
        Women Exclusion&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillherme Godoy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharon Harrison</last_name>
    <phone>713-798-2240</phone>
    <email>sharons@bcm.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guilherme Godoy, MD</last_name>
      <phone>713-798-4001</phone>
      <email>godoy@bcm.edu</email>
    </contact>
    <investigator>
      <last_name>Guilherme Godoy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Guilherme Godoy</investigator_full_name>
    <investigator_title>Assistant Professor of Urology</investigator_title>
  </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>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/NCT02992990
org study id: H-40414
nct id: NCT02992990
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess whether the addition of a bladder tumor biopsy improves the level of agreement
      between the pretreatment endoscopic impression and the final postoperative pathology
      determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.
Non-invasive bladder cancer is challenging to treat because it is a condition characterized
      by frequent recurrences that lead to numerous invasive procedures for detection and
      treatment. The mainstay of therapy for non-muscle invasive bladder cancer, which has remained
      unchanged for decades, relies on surgical resection (TUR) associated with utilization of
      intravesical immunotherapy and chemotherapy. Despite our best efforts, these tumors continue
      to have suboptimal rates of recurrence and require long-term follow-up with costly and
      invasive procedures. The rationale for this study is to show that the preoperative biopsy,
      taken at the time of the office cystoscopic evaluation, improves pre-TUR staging and grading
      correlation with the final pathology of the resection. Indirectly, this will suggest that the
      routine use of pre-TUR biopsy provides more accurate information for intraoperative
      decision-making that can ultimately lead to better management of these patients with
      non-muscle-invasive bladder cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Improvement of the kappa agreement score between preoperative and postoperative assessment of stage and grade in non-muscle-invasive bladder tumors.
time frame: 3 years
description: Assessment of grade, which is the main endpoint will be dichotomous defining lesions between low versus high grade. Stage classification of non-muscle-invasive papillary lesions is also dichotomous between Ta and T1 lesions. CIS can be annotated, but since these are flat, diffuse and non "resectable" in the bladder, they are not part of our main analysis, endpoints, or sample size calculations. The only exception is when the presence of CIS is used to determine grade (high-grade lesion).
arm group label: Bladder tumor biopsy
arm group type: Other
description: All subjects will undergo a bladder tumor biopsy followed by transurethral resection.
intervention type: Procedure
intervention name: Bladder tumor biopsy
description: Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.
arm group label: Bladder tumor biopsy
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Guillherme Godoy, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
last name: Sharon Harrison
phone: 713-798-2240
email: sharons@bcm.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Guilherme Godoy
investigator title: Assistant Professor of Urology
mesh term: Urinary Bladder Neoplasms
sharing ipd: No