<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/NCT03759717</url>
  </required_header>
  <id_info>
    <org_study_id>18070686</org_study_id>
    <nct_id>NCT03759717</nct_id>
  </id_info>
  <brief_title>Molecular and Cellular Characterization of Skull Base Tumors</brief_title>
  <official_title>Molecular and Cellular Characterization of Skull Base Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to analyze biological samples and genetic material for basic&#xD;
      science research investigating the molecular and cellular characterization of skull base&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this proposal is to determine new molecular and cellular features that&#xD;
      define tumor subtypes that are clinically actionable, may drive important changes in patient&#xD;
      management, and/or elucidate novel chemotherapeutic options. Skull base tumors are currently&#xD;
      diagnosed based on histopathologic criteria, on which post-operative management is based.&#xD;
      However, the investigators hypothesize that each tumor type (eg. chordoma or chondrosarcoma)&#xD;
      will have molecular and/or cellular subcategories that will redefine how to categorize and&#xD;
      diagnose patients, predict clinical outcome, and optimally design a patient-specific&#xD;
      management strategy. In addition, we aim to catalogue changes that occur after treatment&#xD;
      after surgical resection, chemotherapy, and/or radiation by comparing primary and recurrent&#xD;
      tumors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 3, 2018</start_date>
  <completion_date type="Anticipated">October 3, 2028</completion_date>
  <primary_completion_date type="Anticipated">October 3, 2028</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient overall survival will be measured and reported.</measure>
    <time_frame>Through study completion, an average of 10 years</time_frame>
    <description>There will be one outcome measure: overall survival.</description>
  </primary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Skull Base Neoplasm</condition>
  <condition>Cellular Pathology</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>Understanding the biology of skull base tumors will teach the investigators about the genesis and/or mechanisms of treatment resistance. The investigators hope to ultimately identify new targets which will add to the armamentarium by which to treat these tumors.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and Tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a skull base tumor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a skull base tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient tumor sample at time of resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Paul Gardner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benita Valappil, MPH</last_name>
    <phone>412-864-1744</phone>
    <email>valappilb2@upmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benita Valappil, MPH</last_name>
      <phone>412-864-1744</phone>
      <email>valappilb2@upmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Paul Gardner</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skull Base Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>If data is to be shared it will be de-identified with proper data use agreements in place.</ipd_description>
  </patient_data>
  <!-- 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/NCT03759717
org study id: 18070686
nct id: NCT03759717
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to analyze biological samples and genetic material for basic
      science research investigating the molecular and cellular characterization of skull base
      tumors.
The overall goal of this proposal is to determine new molecular and cellular features that
      define tumor subtypes that are clinically actionable, may drive important changes in patient
      management, and/or elucidate novel chemotherapeutic options. Skull base tumors are currently
      diagnosed based on histopathologic criteria, on which post-operative management is based.
      However, the investigators hypothesize that each tumor type (eg. chordoma or chondrosarcoma)
      will have molecular and/or cellular subcategories that will redefine how to categorize and
      diagnose patients, predict clinical outcome, and optimally design a patient-specific
      management strategy. In addition, we aim to catalogue changes that occur after treatment
      after surgical resection, chemotherapy, and/or radiation by comparing primary and recurrent
      tumors.
observational model: Cohort
time perspective: Prospective
measure: Patient overall survival will be measured and reported.
time frame: Through study completion, an average of 10 years
description: There will be one outcome measure: overall survival.
intervention type: Other
intervention name: Observation
description: Understanding the biology of skull base tumors will teach the investigators about the genesis and/or mechanisms of treatment resistance. The investigators hope to ultimately identify new targets which will add to the armamentarium by which to treat these tumors.
Blood and Tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Paul Gardner, MD
role: Principal Investigator
affiliation: Associate Professor
last name: Benita Valappil, MPH
phone: 412-864-1744
email: valappilb2@upmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Paul Gardner
investigator title: Associate Professor
mesh term: Skull Base Neoplasms
sharing ipd: No
ipd description: If data is to be shared it will be de-identified with proper data use agreements in place.