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/NCT06040229</url>
    </required_header>
    <id_info>
      <org_study_id>Children's Oncology Group</org_study_id>
      <nct_id>NCT06040229</nct_id>
    </id_info>
    <brief_title>Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma</brief_title>
    <official_title>Mechanism of Children With Relapsed and Refractory Rhabdomyosarcoma (RMS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shandong First Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shandong Tumor Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shandong First Medical University</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>
        This retrospective study is looking into mechanisms of drug therapy resistance in FFPE&#xD;
        samples in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients who have&#xD;
        experienced lung recurrence. The study employs advanced techniques such as single-cell&#xD;
        transcriptomics and spatial transcriptomics to gain a comprehensive understanding of these&#xD;
        mechanisms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research seeks to enhance our understanding of drug resistance mechanisms in recurrent&#xD;
        and refractory RMS in pediatric patients, particularly in the context of lung recurrence. The&#xD;
        utilization of cutting-edge techniques like single-cell transcriptomics and spatial&#xD;
        transcriptomics allows for a more in-depth and comprehensive analysis of the molecular and&#xD;
        spatial aspects of drug resistance in this challenging pediatric cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Gene expression pattern</measure>
      <time_frame>2023.12.31</time_frame>
      <description>Identification and characterization of specific genetic alterations and gene expression patterns associated with drug therapy resistance in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients, particularly in cases of lung recurrence, using single-cell transcriptomics and spatial transcriptomics.</description>
    </primary_outcome>
    <enrollment type="Actual">6</enrollment>
    <condition>Alveolar Childhood Rhabdomyosarcoma</condition>
    <condition>Embryonal Childhood Rhabdomyosarcoma</condition>
    <condition>Recurrent Childhood Rhabdomyosarcoma</condition>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        FFPE samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All participants have previously been diagnosed with RMS, a rare and aggressive form of&#xD;
          pediatric soft tissue cancer. Importantly, their RMS cases are characterized by recurrence,&#xD;
          indicating that the cancer has returned after initial treatment, and refractoriness,&#xD;
          meaning it has not responded well to standard therapies.&#xD;
  &#xD;
          A defining feature of the study population is the presence of documented lung recurrence.&#xD;
          This signifies that the RMS has re-emerged specifically within the lung tissue. Lung&#xD;
          recurrence is a critical clinical aspect being investigated in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pediatric Patients: Participants in this study should be pediatric patients, typically&#xD;
               defined as individuals aged from infancy to 18 years old, who have been diagnosed with&#xD;
               recurrent and refractory Rhabdomyosarcoma (RMS).&#xD;
  &#xD;
            2. Lung Recurrence: Included patients must have a documented history of lung recurrence&#xD;
               of RMS as a specific clinical manifestation.&#xD;
  &#xD;
            3. Availability of FFPE Samples: Patients for whom formalin-fixed paraffin-embedded&#xD;
               (FFPE) tissue samples are available for analysis are eligible for inclusion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Other Histological Types: Patients with RMS of histological subtypes other than those&#xD;
               relevant to the study focus are excluded.&#xD;
  &#xD;
            2. Incomplete Clinical Data: Patients with incomplete or insufficient clinical data&#xD;
               necessary for the study's objectives may be excluded to ensure robust analysis and&#xD;
               interpretation of results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tao Xu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shandong First Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jinan central hospital affiliated to Shandong First Medical University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250017</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rhabdomyosarcoma</mesh_term>
      <mesh_term>Rhabdomyosarcoma, Embryonal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06040229
  org study id: Children's Oncology Group
  nct id: NCT06040229
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This retrospective study is looking into mechanisms of drug therapy resistance in FFPE
        samples in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients who have
        experienced lung recurrence. The study employs advanced techniques such as single-cell
        transcriptomics and spatial transcriptomics to gain a comprehensive understanding of these
        mechanisms.
  This research seeks to enhance our understanding of drug resistance mechanisms in recurrent
        and refractory RMS in pediatric patients, particularly in the context of lung recurrence. The
        utilization of cutting-edge techniques like single-cell transcriptomics and spatial
        transcriptomics allows for a more in-depth and comprehensive analysis of the molecular and
        spatial aspects of drug resistance in this challenging pediatric cancer.
  observational model: Cohort
  time perspective: Retrospective
  measure: Gene expression pattern
  time frame: 2023.12.31
  description: Identification and characterization of specific genetic alterations and gene expression patterns associated with drug therapy resistance in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients, particularly in cases of lung recurrence, using single-cell transcriptomics and spatial transcriptomics.
  FFPE samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 18 Years
  healthy volunteers: No
  last name: Tao Xu
  role: Principal Investigator
  affiliation: Shandong First Medical University
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Rhabdomyosarcoma
  mesh term: Rhabdomyosarcoma, Embryonal
  sharing ipd: Undecided