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/NCT05967481</url>
    </required_header>
    <id_info>
      <org_study_id>84454037</org_study_id>
      <nct_id>NCT05967481</nct_id>
    </id_info>
    <brief_title>Evaluation of Study Experiences of Neuroendocrine Tumor Patients</brief_title>
    <official_title>Investigating the Clinical Trial Journey and Engagement of Neuroendocrine Tumor Patients</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>
        Taking part in clinical trials usually favors a particular demographic group. But there is&#xD;
        limited research available to explain what trial attributes affect the completion of these&#xD;
        specific demographic groups.&#xD;
  &#xD;
        This research will admit a wide range of data on the clinical study experience of&#xD;
        neuroendocrine tumor patients to determine which factors prevail in limiting a patient's&#xD;
        ability to join or finish a trial.&#xD;
  &#xD;
        It will also try to analyze data from the perspective of different demographic groups to&#xD;
        check for recurring trends which might yield insights for the sake of future patients with&#xD;
        neuroendocrine tumor.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2024</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 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>Rate of patients who decide to join in a neuroendocrine tumor clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of neuroendocrine tumor patients who remain in clinical trial until completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Neuroendocrine Tumors</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with neuroendocrine tumor who are actively considering enrolling in a clinical&#xD;
          study, 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 is at least 18 years of age&#xD;
  &#xD;
            -  Diagnosis of neuroendocrine tumor&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Enrolled in another research study&#xD;
  &#xD;
            -  Patients with psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements&#xD;
  &#xD;
            -  Pregnant or lactating woman&#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>Walter T, Krzyzanowska MK. Quality of clinical trials in gastroenteropancreatic neuroendocrine tumours. Neuroendocrinology. 2012;96(3):238-48. doi: 10.1159/000337662. Epub 2012 Aug 28.</citation>
      <PMID>22414794</PMID>
    </reference>
    <reference>
      <citation>Faggiano A, Malandrino P, Modica R, Agrimi D, Aversano M, Bassi V, Giordano EA, Guarnotta V, Logoluso FA, Messina E, Nicastro V, Nuzzo V, Sciaraffia M, Colao A. Efficacy and Safety of Everolimus in Extrapancreatic Neuroendocrine Tumor: A Comprehensive Review of Literature. Oncologist. 2016 Jul;21(7):875-86. doi: 10.1634/theoncologist.2015-0420. Epub 2016 Apr 6.</citation>
      <PMID>27053503</PMID>
    </reference>
    <reference>
      <citation>Capdevila J, Teule A, Barriuso J, Castellano D, Lopez C, Manzano JL, Alonso V, Garcia-Carbonero R, Dotor E, Matos I, Custodio A, Casanovas O, Salazar R; EVERLAR study investigators. Phase II Study of Everolimus and Octreotide LAR in Patients with Nonfunctioning Gastrointestinal Neuroendocrine Tumors: The GETNE1003_EVERLAR Study. Oncologist. 2019 Jan;24(1):38-46. doi: 10.1634/theoncologist.2017-0622. Epub 2018 May 23.</citation>
      <PMID>29794066</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>neuroendocrine tumor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuroendocrine Tumors</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>July 21, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT05967481/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/NCT05967481
  org study id: 84454037
  nct id: NCT05967481
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Taking part in clinical trials usually favors a particular demographic group. But there is
        limited research available to explain what trial attributes affect the completion of these
        specific demographic groups.
  
        This research will admit a wide range of data on the clinical study experience of
        neuroendocrine tumor patients to determine which factors prevail in limiting a patient's
        ability to join or finish a trial.
  
        It will also try to analyze data from the perspective of different demographic groups to
        check for recurring trends which might yield insights for the sake of future patients with
        neuroendocrine tumor.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Rate of patients who decide to join in a neuroendocrine tumor clinical research
  time frame: 3 months
  measure: Number of neuroendocrine tumor patients who remain in clinical trial until 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: Walter T, Krzyzanowska MK. Quality of clinical trials in gastroenteropancreatic neuroendocrine tumours. Neuroendocrinology. 2012;96(3):238-48. doi: 10.1159/000337662. Epub 2012 Aug 28.
  PMID: 22414794
  citation: Faggiano A, Malandrino P, Modica R, Agrimi D, Aversano M, Bassi V, Giordano EA, Guarnotta V, Logoluso FA, Messina E, Nicastro V, Nuzzo V, Sciaraffia M, Colao A. Efficacy and Safety of Everolimus in Extrapancreatic Neuroendocrine Tumor: A Comprehensive Review of Literature. Oncologist. 2016 Jul;21(7):875-86. doi: 10.1634/theoncologist.2015-0420. Epub 2016 Apr 6.
  PMID: 27053503
  citation: Capdevila J, Teule A, Barriuso J, Castellano D, Lopez C, Manzano JL, Alonso V, Garcia-Carbonero R, Dotor E, Matos I, Custodio A, Casanovas O, Salazar R; EVERLAR study investigators. Phase II Study of Everolimus and Octreotide LAR in Patients with Nonfunctioning Gastrointestinal Neuroendocrine Tumors: The GETNE1003_EVERLAR Study. Oncologist. 2019 Jan;24(1):38-46. doi: 10.1634/theoncologist.2017-0622. Epub 2018 May 23.
  PMID: 29794066
  responsible party type: Sponsor
  mesh term: Neuroendocrine Tumors
  sharing ipd: Undecided
  provided document: 