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/NCT05998798</url>
    </required_header>
    <id_info>
      <org_study_id>82379206</org_study_id>
      <nct_id>NCT05998798</nct_id>
    </id_info>
    <brief_title>Revealing Engagement Patterns Among Endometrial Cancer Patients</brief_title>
    <official_title>A Journey Endometrial Cancer Clinical Trials - Revealing Engagement Patterns Among Individuals Affected by Endometrial 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 intends to investigate the personal experiences of endometrial cancer patients who&#xD;
        take part in a separate clinical study including a specific medication intervention. The&#xD;
        major focus will be on closely following individuals' rates of trial completion and&#xD;
        withdrawal.&#xD;
  &#xD;
        The data collected from this study will help improve future outcomes for all endometrial&#xD;
        cancer patients as well as those in under-represented demographic groups.&#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 enroll in an endometrial cancer clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in an endometrial cancer clinical trial to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Endometrial Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with endometrial cancer who are actively considering enrolling in an&#xD;
          interventional clinical trial for said condition, but have not yet completed enrollment and&#xD;
          randomization phases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with endometrial cancer&#xD;
  &#xD;
            -  Aged ≥ 18 years old and ability to provide written informed consent obtained prior to&#xD;
               participation in the study and any related procedures being performed&#xD;
  &#xD;
            -  Subjects willing and able to comply with the protocol for the duration of the study&#xD;
               including undergoing treatment and scheduled visits and examination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of consent&#xD;
  &#xD;
            -  Women of childbearing potential without a negative pregnancy test; or women who are&#xD;
               lactating.&#xD;
  &#xD;
            -  Any serious and/or unstable pre-existing medical disorders&#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>(415) 900-4227</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>O'Malley DM, Bariani GM, Cassier PA, Marabelle A, Hansen AR, De Jesus Acosta A, Miller WH Jr, Safra T, Italiano A, Mileshkin L, Xu L, Jin F, Norwood K, Maio M. Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study. J Clin Oncol. 2022 Mar 1;40(7):752-761. doi: 10.1200/JCO.21.01874. Epub 2022 Jan 6.</citation>
      <PMID>34990208</PMID>
    </reference>
    <reference>
      <citation>Marth C, Tarnawski R, Tyulyandina A, Pignata S, Gilbert L, Kaen D, Rubio MJ, Frentzas S, Beiner M, Magallanes-Maciel M, Farrelly L, Choi CH, Berger R, Lee C, Vulsteke C, Hasegawa K, Braicu EI, Wu X, McKenzie J, Lee JJ, Makker V. Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001. Int J Gynecol Cancer. 2022 Jan;32(1):93-100. doi: 10.1136/ijgc-2021-003017. Epub 2021 Nov 19.</citation>
      <PMID>34799418</PMID>
    </reference>
    <reference>
      <citation>Stelloo E, Nout RA, Osse EM, Jurgenliemk-Schulz IJ, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Nijman HW, Putter H, Bosse T, Creutzberg CL, Smit VT. Improved Risk Assessment by Integrating Molecular and Clinicopathological Factors in Early-stage Endometrial Cancer-Combined Analysis of the PORTEC Cohorts. Clin Cancer Res. 2016 Aug 15;22(16):4215-24. doi: 10.1158/1078-0432.CCR-15-2878. Epub 2016 Mar 22.</citation>
      <PMID>27006490</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>endometrial cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial 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 11, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT05998798/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/NCT05998798
  org study id: 82379206
  nct id: NCT05998798
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study intends to investigate the personal experiences of endometrial cancer patients who
        take part in a separate clinical study including a specific medication intervention. The
        major focus will be on closely following individuals' rates of trial completion and
        withdrawal.
  
        The data collected from this study will help improve future outcomes for all endometrial
        cancer patients as well as those in under-represented demographic groups.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to enroll in an endometrial cancer clinical research
  time frame: 3 months
  measure: Rate of patients who remain in an endometrial cancer clinical trial 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: (415) 900-4227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: O'Malley DM, Bariani GM, Cassier PA, Marabelle A, Hansen AR, De Jesus Acosta A, Miller WH Jr, Safra T, Italiano A, Mileshkin L, Xu L, Jin F, Norwood K, Maio M. Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study. J Clin Oncol. 2022 Mar 1;40(7):752-761. doi: 10.1200/JCO.21.01874. Epub 2022 Jan 6.
  PMID: 34990208
  citation: Marth C, Tarnawski R, Tyulyandina A, Pignata S, Gilbert L, Kaen D, Rubio MJ, Frentzas S, Beiner M, Magallanes-Maciel M, Farrelly L, Choi CH, Berger R, Lee C, Vulsteke C, Hasegawa K, Braicu EI, Wu X, McKenzie J, Lee JJ, Makker V. Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001. Int J Gynecol Cancer. 2022 Jan;32(1):93-100. doi: 10.1136/ijgc-2021-003017. Epub 2021 Nov 19.
  PMID: 34799418
  citation: Stelloo E, Nout RA, Osse EM, Jurgenliemk-Schulz IJ, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Nijman HW, Putter H, Bosse T, Creutzberg CL, Smit VT. Improved Risk Assessment by Integrating Molecular and Clinicopathological Factors in Early-stage Endometrial Cancer-Combined Analysis of the PORTEC Cohorts. Clin Cancer Res. 2016 Aug 15;22(16):4215-24. doi: 10.1158/1078-0432.CCR-15-2878. Epub 2016 Mar 22.
  PMID: 27006490
  responsible party type: Sponsor
  mesh term: Endometrial Neoplasms
  sharing ipd: Undecided
  provided document: 