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/NCT06039033</url>
    </required_header>
    <id_info>
      <org_study_id>90700326</org_study_id>
      <nct_id>NCT06039033</nct_id>
    </id_info>
    <brief_title>Exploring Merkel Cell Carcinoma Clinical Trial Engagement Patterns</brief_title>
    <official_title>Merkel Cell Carcinoma Clinical Trials: What Are Prevailing Patient Experiences in Merkel Cell Carcinoma Studies</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 medical research 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 study will admit a wide range of data on the clinical trial experience of Merkel cell&#xD;
        carcinoma patients to determine which factors prevail in limiting a patient's ability to join&#xD;
        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 Merkel cell&#xD;
        carcinoma patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2024</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">October 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 Merkel cell carcinoma clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in Merkel cell carcinoma clinical research to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Merkel Cell Carcinoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Merkel cell carcinoma who are actively considering enrolling in a clinical&#xD;
          trial, but have not yet completed enrollment and randomization phases in said clinical&#xD;
          trial.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged ≥ 18 years old&#xD;
  &#xD;
            -  Able to comprehend the investigational nature of the protocol and provide informed&#xD;
               consent&#xD;
  &#xD;
            -  Diagnosis of Merkel cell carcinoma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No diagnosis of Merkel cell carcinoma confirmed&#xD;
  &#xD;
            -  Inability to perform regular electronic reporting&#xD;
  &#xD;
            -  Patient does not understand, sign, and return consent form&#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>Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbe C, Robert C, Russell J, Guzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naive Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.</citation>
      <PMID>32472503</PMID>
    </reference>
    <reference>
      <citation>Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1.</citation>
      <PMID>27592805</PMID>
    </reference>
    <reference>
      <citation>Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbe C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.</citation>
      <PMID>32324435</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Merkel Cell Carcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Merkel Cell</mesh_term>
      <mesh_term>Carcinoma</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>September 8, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT06039033/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/NCT06039033
  org study id: 90700326
  nct id: NCT06039033
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Taking part in medical research 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 study will admit a wide range of data on the clinical trial experience of Merkel cell
        carcinoma 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 Merkel cell
        carcinoma patients.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to enroll in a Merkel cell carcinoma clinical research
  time frame: 3 months
  measure: Rate of patients who remain in Merkel cell carcinoma 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: 415-900-4227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbe C, Robert C, Russell J, Guzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naive Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.
  PMID: 32472503
  citation: Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1.
  PMID: 27592805
  citation: Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbe C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.
  PMID: 32324435
  responsible party type: Sponsor
  mesh term: Carcinoma, Merkel Cell
  mesh term: Carcinoma
  sharing ipd: Undecided
  provided document: 