<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/NCT01668095</url>
  </required_header>
  <id_info>
    <org_study_id>ARST12B8</org_study_id>
    <secondary_id>NCI-2012-01997</secondary_id>
    <secondary_id>COG-ARST12B8</secondary_id>
    <secondary_id>CDR0000738499</secondary_id>
    <secondary_id>ARST12B8</secondary_id>
    <secondary_id>ARST12B8</secondary_id>
    <nct_id>NCT01668095</nct_id>
  </id_info>
  <brief_title>Biomarkers in Patients With Advanced Rhabdomyosarcoma</brief_title>
  <official_title>Developmental Pathway Drug-Targets in Advanced Rhabdomyosarcomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Oncology Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research trial studies tumor tissue to identify important proteins and biomarkers from&#xD;
      patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot&#xD;
      be cured or controlled with treatment. Studying samples of tumor tissue from patients with&#xD;
      cancer in the laboratory may help doctors identify biomarkers related to cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To investigate whether the expression of a subset of proteins (by immunohistochemistry),&#xD;
      known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development&#xD;
      pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in&#xD;
      each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Adult Rhabdomyosarcoma</condition>
  <condition>Childhood Alveolar Rhabdomyosarcoma</condition>
  <condition>Childhood Embryonal Rhabdomyosarcoma</condition>
  <condition>Previously Treated Childhood Rhabdomyosarcoma</condition>
  <condition>Recurrent Adult Soft Tissue Sarcoma</condition>
  <condition>Recurrent Childhood Rhabdomyosarcoma</condition>
  <condition>Stage III Adult Soft Tissue Sarcoma</condition>
  <condition>Stage IV Adult Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>Ancillary-Correlative (biomarker analysis)</arm_group_label>
    <description>Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Ancillary-Correlative (biomarker analysis)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tumor tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rhabdomyosarcoma that has spread to other places in the body and usually&#xD;
        cannot be cured or controlled with treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  8 tissue microarrays (TMA) slides of the following diseases available:&#xD;
&#xD;
               -  Alveolar rhabdomyosarcoma&#xD;
&#xD;
               -  Embryonal rhabdomyosarcoma&#xD;
&#xD;
               -  Anaplastic rhabdomyosarcoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Keller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Oncology Group</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>May 17, 2016</last_update_submitted>
  <last_update_submitted_qc>May 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 18, 2016</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>Sarcoma</mesh_term>
    <mesh_term>Rhabdomyosarcoma</mesh_term>
    <mesh_term>Rhabdomyosarcoma, Embryonal</mesh_term>
    <mesh_term>Rhabdomyosarcoma, Alveolar</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01668095
org study id: ARST12B8
secondary id: NCI-2012-01997
secondary id: COG-ARST12B8
secondary id: CDR0000738499
secondary id: ARST12B8
secondary id: ARST12B8
nct id: NCT01668095
lead sponsor: 
collaborator: 
has dmc: No
This research trial studies tumor tissue to identify important proteins and biomarkers from
      patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot
      be cured or controlled with treatment. Studying samples of tumor tissue from patients with
      cancer in the laboratory may help doctors identify biomarkers related to cancer.
PRIMARY OBJECTIVES:

      I. To investigate whether the expression of a subset of proteins (by immunohistochemistry),
      known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development
      pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.

      OUTLINE:

      Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in
      each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray
      analysis.
observational model: Case-Only
time perspective: Retrospective
measure: Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma
time frame: 1 month
arm group label: Ancillary-Correlative (biomarker analysis)
description: Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Ancillary-Correlative (biomarker analysis)
tumor tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Charles Keller, MD
role: Principal Investigator
affiliation: Children's Oncology Group
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Rhabdomyosarcoma
mesh term: Rhabdomyosarcoma, Embryonal
mesh term: Rhabdomyosarcoma, Alveolar
mesh term: Recurrence