<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/NCT04432532</url>
  </required_header>
  <id_info>
    <org_study_id>832475</org_study_id>
    <nct_id>NCT04432532</nct_id>
  </id_info>
  <brief_title>Neuroendocrine and Adrenal Tumors</brief_title>
  <acronym>NETAT</acronym>
  <official_title>Neuroendocrine and Adrenal Tumors: Biochemical, Histopathologic and Genetic Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be&#xD;
      enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is&#xD;
      designed to work in conjunction with IRB#831990 which is a retrospective protocol. The&#xD;
      University of Pennsylvania will be a contributing site with the University of Michigan as the&#xD;
      coordinating site for the A5 alliance, a multi-institutional collaborative designed to study&#xD;
      neuroendocrine and adrenal tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2023</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor Recurrence</measure>
    <time_frame>10 years</time_frame>
    <description>We want to record recurrences in our patient population</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">999</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <condition>Adrenal Tumor</condition>
  <arm_group>
    <arm_group_label>Neuroendocrine Tumor</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Adrenal Tumor</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>There are no interventions</description>
    <arm_group_label>Adrenal Tumor</arm_group_label>
    <arm_group_label>Neuroendocrine Tumor</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor specimens, blood and/or saliva samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed and seeking treatment for neuroendocrine tumors or adrenal tumors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with neuroendocrine and/or an adrenal tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  people under the age of 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Heather Wachtel</last_name>
    <phone>2156622341</phone>
    <email>heather.wachtel@pennmedicine.upenn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wajid Amjad</last_name>
    <email>Wajid.Amjad@pennmedicine.upenn.edu</email>
  </overall_contact_backup>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>March 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Heather Wachtel, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Adrenal Gland Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </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/NCT04432532
org study id: 832475
nct id: NCT04432532
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be
      enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is
      designed to work in conjunction with IRB#831990 which is a retrospective protocol. The
      University of Pennsylvania will be a contributing site with the University of Michigan as the
      coordinating site for the A5 alliance, a multi-institutional collaborative designed to study
      neuroendocrine and adrenal tumors.
observational model: Case-Control
time perspective: Prospective
measure: Survival
time frame: 10 years
measure: Tumor Recurrence
time frame: 10 years
description: We want to record recurrences in our patient population
arm group label: Neuroendocrine Tumor
arm group label: Adrenal Tumor
intervention type: Other
intervention name: No intervention
description: There are no interventions
arm group label: Adrenal Tumor
arm group label: Neuroendocrine Tumor
Tumor specimens, blood and/or saliva samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Heather Wachtel
phone: 2156622341
email: heather.wachtel@pennmedicine.upenn.edu
last name: Wajid Amjad
email: Wajid.Amjad@pennmedicine.upenn.edu
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Heather Wachtel, MD
investigator title: Assistant Professor of Surgery
mesh term: Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Adrenal Gland Neoplasms
sharing ipd: Yes