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/NCT06009510</url>
    </required_header>
    <id_info>
      <org_study_id>87986229</org_study_id>
      <nct_id>NCT06009510</nct_id>
    </id_info>
    <brief_title>Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer</brief_title>
    <official_title>Participation Trends in Bladder Cancer Clinical Trials - Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Power Life Sciences Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Power Life Sciences Inc.</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 study seeks to delve into the firsthand experiences of patients diagnosed with bladder&#xD;
        cancer who partake in a separate clinical trial featuring a specific medical intervention.&#xD;
        The primary emphasis will be on meticulously tracking the rates of trial completion and&#xD;
        withdrawal among these individuals.&#xD;
  &#xD;
        By joining this clinical trial, individuals have the unique opportunity to contribute to the&#xD;
        betterment of future bladder cancer patients and play an active role in advancing medical&#xD;
        research.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2024</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients who decide to participate in a bladder cancer clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in bladder cancer clinical research to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Bladder Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Bladder cancer patients who are actively considering enrolling in an observational clinical&#xD;
          trial, but have not yet completed enrollment and randomization.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient has self-identified as planning to enroll in a clinical trial&#xD;
  &#xD;
            -  Patient has been diagnosed with bladder cancer&#xD;
  &#xD;
            -  Patient is a minimum of 18 years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient does not understand, sign, and return consent form&#xD;
  &#xD;
            -  Inability to perform regular electronic reporting&#xD;
  &#xD;
            -  Patient is pregnant&#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>Michael B Gill</last_name>
      <role>Study Director</role>
      <affiliation>Power Life Sciences Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael B Gill</last_name>
      <phone>4159004227</phone>
      <email>bask@withpower.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Power Life Sciences</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael B Gill</last_name>
        <phone>415-900-4227</phone>
        <email>https://www.withpower.com/contact-us@withpower.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Ng K, Stenzl A, Sharma A, Vasdev N. Urinary biomarkers in bladder cancer: A review of the current landscape and future directions. Urol Oncol. 2021 Jan;39(1):41-51. doi: 10.1016/j.urolonc.2020.08.016. Epub 2020 Sep 9.</citation>
      <PMID>32919875</PMID>
    </reference>
    <reference>
      <citation>Gaya JM, Territo A, Woldu S, Schwartzmann I, Verri P, Gonzalez-Perez L, Cozar JM, Minana B, Medina RA, de la Rosa-Kehrmann F, Lozano-Palacio F, Ribal MJ, Hernandez C, Castineiras JJ, Requena MJ, Moreno J, Caraballido JA, Baena V, Breda A, Palou Redorta J. Incidental diagnosis of bladder cancer in a national observational study in spain. Actas Urol Esp (Engl Ed). 2023 Jun;47(5):296-302. doi: 10.1016/j.acuroe.2022.09.005. Epub 2022 Oct 1. English, Spanish.</citation>
      <PMID>36443223</PMID>
    </reference>
    <reference>
      <citation>Malhotra B, Hiteshi P, Khalkho P, Malik R, Bhadada SK, Bhansali A, Shafiq N, Malhotra S, Kumar N, Rajput R, Rastogi A. Bladder cancer with pioglitazone: A case-control study. Diabetes Metab Syndr. 2022 Nov;16(11):102637. doi: 10.1016/j.dsx.2022.102637. Epub 2022 Oct 8.</citation>
      <PMID>36270237</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bladder cancer</keyword>
    <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>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 18, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT06009510/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06009510
  org study id: 87986229
  nct id: NCT06009510
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study seeks to delve into the firsthand experiences of patients diagnosed with bladder
        cancer who partake in a separate clinical trial featuring a specific medical intervention.
        The primary emphasis will be on meticulously tracking the rates of trial completion and
        withdrawal among these individuals.
  
        By joining this clinical trial, individuals have the unique opportunity to contribute to the
        betterment of future bladder cancer patients and play an active role in advancing medical
        research.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to participate in a bladder cancer clinical research
  time frame: 3 months
  measure: Rate of patients who remain in bladder cancer clinical research to trial completion
  time frame: 12 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael B Gill
  role: Study Director
  affiliation: Power Life Sciences Inc.
  last name: Michael B Gill
  phone: 4159004227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Ng K, Stenzl A, Sharma A, Vasdev N. Urinary biomarkers in bladder cancer: A review of the current landscape and future directions. Urol Oncol. 2021 Jan;39(1):41-51. doi: 10.1016/j.urolonc.2020.08.016. Epub 2020 Sep 9.
  PMID: 32919875
  citation: Gaya JM, Territo A, Woldu S, Schwartzmann I, Verri P, Gonzalez-Perez L, Cozar JM, Minana B, Medina RA, de la Rosa-Kehrmann F, Lozano-Palacio F, Ribal MJ, Hernandez C, Castineiras JJ, Requena MJ, Moreno J, Caraballido JA, Baena V, Breda A, Palou Redorta J. Incidental diagnosis of bladder cancer in a national observational study in spain. Actas Urol Esp (Engl Ed). 2023 Jun;47(5):296-302. doi: 10.1016/j.acuroe.2022.09.005. Epub 2022 Oct 1. English, Spanish.
  PMID: 36443223
  citation: Malhotra B, Hiteshi P, Khalkho P, Malik R, Bhadada SK, Bhansali A, Shafiq N, Malhotra S, Kumar N, Rajput R, Rastogi A. Bladder cancer with pioglitazone: A case-control study. Diabetes Metab Syndr. 2022 Nov;16(11):102637. doi: 10.1016/j.dsx.2022.102637. Epub 2022 Oct 8.
  PMID: 36270237
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  sharing ipd: Undecided
  provided document: 