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/NCT06029465</url>
    </required_header>
    <id_info>
      <org_study_id>84447609</org_study_id>
      <nct_id>NCT06029465</nct_id>
    </id_info>
    <brief_title>Analyzing Engagement Trends in Rhabdomyosarcoma Clinical Trials</brief_title>
    <official_title>Analyzing Engagement Trends in Rhabdomyosarcoma Clinical Trials: A Study of Participation Patterns Among Those Affected by the Disorder</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&#xD;
        rhabdomyosarcoma who partake in a separate clinical trial featuring a specific medical&#xD;
        intervention. The primary emphasis will be on meticulously tracking the rates of trial&#xD;
        completion and withdrawal among these individuals.&#xD;
  &#xD;
        The data collected from this study will help improve future outcomes for all rhabdomyosarcoma&#xD;
        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">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 rhabdomyosarcoma patients who decide to enroll in a clinical trial</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of rhabdomyosarcoma patients who remain in clinical trial to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Rhabdomyosarcoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with rhabdomyosarcoma who are actively considering enrolling in an observational&#xD;
          clinical study for said condition, but have not yet completed enrollment and randomization&#xD;
          phases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of rhabdomyosarcoma&#xD;
  &#xD;
            -  Considered reliable, able to understand, and willing to perform all study procedures&#xD;
  &#xD;
            -  Signed Written Informed Consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently enrolled in, have completed or have discontinued from a clinical trial&#xD;
               involving an investigational drug&#xD;
  &#xD;
            -  Is pregnant, breastfeeding or expecting to conceive within the projected duration of&#xD;
               the study&#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>Sparber-Sauer M, Ferrari A, Kosztyla D, Ladenstein R, Cecchetto G, Kazanowska B, Scarzello G, Ljungman G, Milano GM, Niggli F, Alaggio R, Vokuhl C, Casanova M, Klingebiel T, Zin A, Koscielniak E, Bisogno G. Long-term results from the multicentric European randomized phase 3 trial CWS/RMS-96 for localized high-risk soft tissue sarcoma in children, adolescents, and young adults. Pediatr Blood Cancer. 2022 Sep;69(9):e29691. doi: 10.1002/pbc.29691. Epub 2022 Apr 19.</citation>
      <PMID>35441463</PMID>
    </reference>
    <reference>
      <citation>Saulnier-Sholler G, Duda DG, Bergendahl G, Ebb D, Snuderl M, Laetsch TW, Michlitsch J, Hanson D, Isakoff MS, Bielamowicz K, Kraveka JM, Ferguson W, Carmeliet P, De Deene A, Gijsen L, Jain RK. A Phase I Trial of TB-403 in Relapsed Medulloblastoma, Neuroblastoma, Ewing Sarcoma, and Alveolar Rhabdomyosarcoma. Clin Cancer Res. 2022 Sep 15;28(18):3950-3957. doi: 10.1158/1078-0432.CCR-22-1169.</citation>
      <PMID>35833850</PMID>
    </reference>
    <reference>
      <citation>Leiner J, Le Loarer F. The current landscape of rhabdomyosarcomas: an update. Virchows Arch. 2020 Jan;476(1):97-108. doi: 10.1007/s00428-019-02676-9. Epub 2019 Nov 6.</citation>
      <PMID>31696361</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rhabdomyosarcoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rhabdomyosarcoma</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 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT06029465/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/NCT06029465
  org study id: 84447609
  nct id: NCT06029465
  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
        rhabdomyosarcoma 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.
  
        The data collected from this study will help improve future outcomes for all rhabdomyosarcoma
        patients as well as those in under-represented demographic groups.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of rhabdomyosarcoma patients who decide to enroll in a clinical trial
  time frame: 3 months
  measure: Rate of rhabdomyosarcoma patients who remain in 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: Sparber-Sauer M, Ferrari A, Kosztyla D, Ladenstein R, Cecchetto G, Kazanowska B, Scarzello G, Ljungman G, Milano GM, Niggli F, Alaggio R, Vokuhl C, Casanova M, Klingebiel T, Zin A, Koscielniak E, Bisogno G. Long-term results from the multicentric European randomized phase 3 trial CWS/RMS-96 for localized high-risk soft tissue sarcoma in children, adolescents, and young adults. Pediatr Blood Cancer. 2022 Sep;69(9):e29691. doi: 10.1002/pbc.29691. Epub 2022 Apr 19.
  PMID: 35441463
  citation: Saulnier-Sholler G, Duda DG, Bergendahl G, Ebb D, Snuderl M, Laetsch TW, Michlitsch J, Hanson D, Isakoff MS, Bielamowicz K, Kraveka JM, Ferguson W, Carmeliet P, De Deene A, Gijsen L, Jain RK. A Phase I Trial of TB-403 in Relapsed Medulloblastoma, Neuroblastoma, Ewing Sarcoma, and Alveolar Rhabdomyosarcoma. Clin Cancer Res. 2022 Sep 15;28(18):3950-3957. doi: 10.1158/1078-0432.CCR-22-1169.
  PMID: 35833850
  citation: Leiner J, Le Loarer F. The current landscape of rhabdomyosarcomas: an update. Virchows Arch. 2020 Jan;476(1):97-108. doi: 10.1007/s00428-019-02676-9. Epub 2019 Nov 6.
  PMID: 31696361
  responsible party type: Sponsor
  mesh term: Rhabdomyosarcoma
  sharing ipd: Undecided
  provided document: 