<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/NCT02203136</url>
  </required_header>
  <id_info>
    <org_study_id>PA13-0942</org_study_id>
    <nct_id>NCT02203136</nct_id>
  </id_info>
  <brief_title>Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging</brief_title>
  <official_title>Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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 research study is to improve detection of cancer outside of the bladder&#xD;
      through genetic testing and improved imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If participant agrees to take part in the study, a piece of the tumor that is removed during&#xD;
      the biopsy will be collected for research purposes. The tissue will be sent to the laboratory&#xD;
      for genetic testing.&#xD;
&#xD;
      If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan&#xD;
      (MRI) recently, information collected from the scan will be collected. If they have not had&#xD;
      one recently, they will have an MRI with contrast as part of this study. They will receive a&#xD;
      separate consent form for this MRI scan.&#xD;
&#xD;
      The results of the test will be given to their doctor, but the results will not be used to&#xD;
      decide their treatment.&#xD;
&#xD;
      After they have surgery, information will be collected from their medical records, such as&#xD;
      their diagnosis.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
        -  Their participation on this study will be over once their surgery is completed.&#xD;
&#xD;
        -  This is an investigational study.&#xD;
&#xD;
      Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2014</start_date>
  <completion_date type="Actual">May 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection Improvement of Cancer Outside of the Bladder</measure>
    <time_frame>4 weeks</time_frame>
    <description>Improved cross sectional imaging with pelvic MRI, and biopsy specimen molecular profiling used to identify muscle invasive bladder cancer (noc-MIBC). Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Muscle Invasive Bladder Cancer (MIBC)</arm_group_label>
    <description>During bladder cancer surgery, whole genome gene expression array assays obtained on tumor biopsy specimens. Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC. 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tissue Biopsy</intervention_name>
    <description>During bladder cancer surgery, tissue specimen taken for molecular profiling.</description>
    <arm_group_label>Muscle Invasive Bladder Cancer (MIBC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.</description>
    <arm_group_label>Muscle Invasive Bladder Cancer (MIBC)</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      At the time of biopsy, a portion of the fresh human tumor biopsy samples utilized for DNA and&#xD;
      RNA extraction.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants scheduled for bladder cancer surgery and biopsy from the Department of Urology&#xD;
        at MD Anderson Cancer Center in Houston, Texas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients with biopsy proven bladder cancer of any age will be eligible for enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia)&#xD;
&#xD;
          2. Participants who have previously received chemotherapy as part of multimodal therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neema Navai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bladder cancer</keyword>
  <keyword>Muscle invasive bladder cancer</keyword>
  <keyword>MIBC</keyword>
  <keyword>Biopsy specimen molecular profiling</keyword>
  <keyword>Bladder surgery</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>MRI</keyword>
  <keyword>Trans urethral resection of bladder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02203136
org study id: PA13-0942
nct id: NCT02203136
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to improve detection of cancer outside of the bladder
      through genetic testing and improved imaging.
If participant agrees to take part in the study, a piece of the tumor that is removed during
      the biopsy will be collected for research purposes. The tissue will be sent to the laboratory
      for genetic testing.

      If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan
      (MRI) recently, information collected from the scan will be collected. If they have not had
      one recently, they will have an MRI with contrast as part of this study. They will receive a
      separate consent form for this MRI scan.

      The results of the test will be given to their doctor, but the results will not be used to
      decide their treatment.

      After they have surgery, information will be collected from their medical records, such as
      their diagnosis.

      Length of Study:

        -  Their participation on this study will be over once their surgery is completed.

        -  This is an investigational study.

      Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
observational model: Cohort
time perspective: Prospective
measure: Detection Improvement of Cancer Outside of the Bladder
time frame: 4 weeks
description: Improved cross sectional imaging with pelvic MRI, and biopsy specimen molecular profiling used to identify muscle invasive bladder cancer (noc-MIBC). Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC.
arm group label: Muscle Invasive Bladder Cancer (MIBC)
description: During bladder cancer surgery, whole genome gene expression array assays obtained on tumor biopsy specimens. Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC. 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.
intervention type: Procedure
intervention name: Tissue Biopsy
description: During bladder cancer surgery, tissue specimen taken for molecular profiling.
arm group label: Muscle Invasive Bladder Cancer (MIBC)
intervention type: Procedure
intervention name: Magnetic Resonance Imaging (MRI)
description: 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.
arm group label: Muscle Invasive Bladder Cancer (MIBC)
other name: MRI
At the time of biopsy, a portion of the fresh human tumor biopsy samples utilized for DNA and
      RNA extraction.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Neema Navai, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms