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/NCT05998811</url>
    </required_header>
    <id_info>
      <org_study_id>82665307</org_study_id>
      <nct_id>NCT05998811</nct_id>
    </id_info>
    <brief_title>Insights Into Participating in Studies for Uterine Cancer</brief_title>
    <official_title>Exploring Uterine Cancer Clinical Trials - Revealing Participation Patterns in Individuals With Uterine 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>
        Clinical study participation has historically been heavily biased toward specific&#xD;
        demographics.&#xD;
  &#xD;
        Several people will be invited to enroll in this trial so that it may collect a variety of&#xD;
        data about uterine cancer clinical study experiences and identify barriers to participation&#xD;
        as well as the causes of participants' failure or withdrawal.&#xD;
  &#xD;
        People with uterine cancer who are invited to take part in medical study will benefit from&#xD;
        the analysis of the data.&#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 a uterine cancer clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in a uterine cancer clinical trial to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Uterine Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Uterine cancer patients who are actively considering enrolling in a clinical trial for the&#xD;
          said condition, but have not yet completed enrollment and randomization phases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#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;
            -  Diagnosis of uterine cancer&#xD;
  &#xD;
            -  No prior treatment for uterine cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
               cooperation with the requirements of the trial&#xD;
  &#xD;
            -  Enrolled in another research study&#xD;
  &#xD;
            -  Inability to provide written informed consent&#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>Filippova OT, Leitao MM. The current clinical approach to newly diagnosed uterine cancer. Expert Rev Anticancer Ther. 2020 Jul;20(7):581-590. doi: 10.1080/14737140.2020.1782750. Epub 2020 Jun 22.</citation>
      <PMID>32531179</PMID>
    </reference>
    <reference>
      <citation>Wang Z, Guo E, Yang B, Xiao R, Lu F, You L, Chen G. Trends and age-period-cohort effects on mortality of the three major gynecologic cancers in China from 1990 to 2019: Cervical, ovarian and uterine cancer. Gynecol Oncol. 2021 Nov;163(2):358-363. doi: 10.1016/j.ygyno.2021.08.029. Epub 2021 Sep 8.</citation>
      <PMID>34507827</PMID>
    </reference>
    <reference>
      <citation>Torres D, Myers JA, Eshraghi LW, Riley EC, Soliman PT, Milam MR. Risk factors for the development of uterine cancer in breast cancer survivors: an army of women study. Ann Surg Oncol. 2015;22(6):1974-9. doi: 10.1245/s10434-014-4193-5. Epub 2014 Nov 1.</citation>
      <PMID>25361886</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>Uterine Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine 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/11/NCT05998811/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/NCT05998811
  org study id: 82665307
  nct id: NCT05998811
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Clinical study participation has historically been heavily biased toward specific
        demographics.
  
        Several people will be invited to enroll in this trial so that it may collect a variety of
        data about uterine cancer clinical study experiences and identify barriers to participation
        as well as the causes of participants' failure or withdrawal.
  
        People with uterine cancer who are invited to take part in medical study will benefit from
        the analysis of the data.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to enroll in a uterine cancer clinical research
  time frame: 3 months
  measure: Rate of patients who remain in a uterine 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: 4159004227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Filippova OT, Leitao MM. The current clinical approach to newly diagnosed uterine cancer. Expert Rev Anticancer Ther. 2020 Jul;20(7):581-590. doi: 10.1080/14737140.2020.1782750. Epub 2020 Jun 22.
  PMID: 32531179
  citation: Wang Z, Guo E, Yang B, Xiao R, Lu F, You L, Chen G. Trends and age-period-cohort effects on mortality of the three major gynecologic cancers in China from 1990 to 2019: Cervical, ovarian and uterine cancer. Gynecol Oncol. 2021 Nov;163(2):358-363. doi: 10.1016/j.ygyno.2021.08.029. Epub 2021 Sep 8.
  PMID: 34507827
  citation: Torres D, Myers JA, Eshraghi LW, Riley EC, Soliman PT, Milam MR. Risk factors for the development of uterine cancer in breast cancer survivors: an army of women study. Ann Surg Oncol. 2015;22(6):1974-9. doi: 10.1245/s10434-014-4193-5. Epub 2014 Nov 1.
  PMID: 25361886
  responsible party type: Sponsor
  mesh term: Uterine Neoplasms
  sharing ipd: Undecided
  provided document: 