<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/NCT03043508</url>
  </required_header>
  <id_info>
    <org_study_id>PA15-0231</org_study_id>
    <nct_id>NCT03043508</nct_id>
  </id_info>
  <brief_title>Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)</brief_title>
  <official_title>Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      OBJECTIVES:&#xD;
&#xD;
      The primary objective of this study is to evaluate the effect of estrogen on the development&#xD;
      of the PNET in MEN1 patients.&#xD;
&#xD;
      The secondary objective is to evaluate the overall survival and disease specific survival in&#xD;
      patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor&#xD;
      in relation to their hormone status. The secondary objective is to evaluate clinicopathologic&#xD;
      features in relation to hormone status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective review of a prospectively maintained MEN1 database. The patient cohort consists&#xD;
      of all patients with confirmed MEN1 with or without PNET who are included in the database.&#xD;
      The database will be reviewed to obtain patient and disease characteristics, laboratory&#xD;
      values, imaging results, hormone parameters (menopausal status, bioidentical hormone use,&#xD;
      oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.&#xD;
&#xD;
      For the prospective portion of this study, investigators want to see the impact of estrogen&#xD;
      on the PNET forming and progression, and would like to use two equations to assess the&#xD;
      estrogen exposure, so investigators should collect the information of menopause, menarche,&#xD;
      breast feed, HRT, OCP use and pregnancy. To this end, investigators will contact female&#xD;
      patients in the database who are still living, and obtain verbal informed consent to send an&#xD;
      email questionnaire regarding their pregnancy and hormone use history.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 10, 2015</start_date>
  <completion_date type="Anticipated">April 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2025</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Pancreatic Neuroendocrine Tumors (PNET)</measure>
    <time_frame>10 years</time_frame>
    <description>Time to PNET calculated starting from the date of menarche time to the PNET diagnostic date or the menopause date (for the patients who get the menopause prior to the PNET diagnosis) or the last follow-up date.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET</measure>
    <time_frame>10 years</time_frame>
    <description>Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Genetic Mutation</condition>
  <condition>MEN1</condition>
  <arm_group>
    <arm_group_label>Participants With Confirmed MEN1 With PNET</arm_group_label>
    <description>Retrospective review of a prospectively maintained MEN1 database.&#xD;
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants With Confirmed MEN1 Without PNET</arm_group_label>
    <description>Retrospective review of a prospectively maintained MEN1 database.&#xD;
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chart Review</intervention_name>
    <description>Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.</description>
    <arm_group_label>Participants With Confirmed MEN1 With PNET</arm_group_label>
    <arm_group_label>Participants With Confirmed MEN1 Without PNET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.</description>
    <arm_group_label>Participants With Confirmed MEN1 With PNET</arm_group_label>
    <arm_group_label>Participants With Confirmed MEN1 Without PNET</arm_group_label>
    <other_name>Survey</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospectively maintained MEN1 database within the Department of Surgical Oncology, Division&#xD;
        of Surgical Endocrinology at the University of Texas MD Anderson Cancer Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient cohort for this study consists of all patients within the prospectively&#xD;
             maintained MEN1 database within the Department of Surgical Oncology at the University&#xD;
             of Texas MD Anderson Cancer Center.&#xD;
&#xD;
          2. Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or&#xD;
             defined clinical criteria were considered.&#xD;
&#xD;
          3. All patients for whom hormone status variables and survival data are available will be&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Due to the nature of the questions included in the prospective estrogen questionnaire,&#xD;
        only female patients will be verbally consented to receive the questionnaire and obtain&#xD;
        prospective data.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy D. Perrier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Genetic mutation</keyword>
  <keyword>MEN1</keyword>
  <keyword>Pancreatic neuroendocrine tumor</keyword>
  <keyword>PNET</keyword>
  <keyword>Chart review</keyword>
  <keyword>Questionnaire</keyword>
  <keyword>Survey</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Adenoma, Islet Cell</mesh_term>
    <mesh_term>Multiple Endocrine Neoplasia Type 1</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/NCT03043508
org study id: PA15-0231
nct id: NCT03043508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
OBJECTIVES:

      The primary objective of this study is to evaluate the effect of estrogen on the development
      of the PNET in MEN1 patients.

      The secondary objective is to evaluate the overall survival and disease specific survival in
      patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor
      in relation to their hormone status. The secondary objective is to evaluate clinicopathologic
      features in relation to hormone status.
Retrospective review of a prospectively maintained MEN1 database. The patient cohort consists
      of all patients with confirmed MEN1 with or without PNET who are included in the database.
      The database will be reviewed to obtain patient and disease characteristics, laboratory
      values, imaging results, hormone parameters (menopausal status, bioidentical hormone use,
      oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

      For the prospective portion of this study, investigators want to see the impact of estrogen
      on the PNET forming and progression, and would like to use two equations to assess the
      estrogen exposure, so investigators should collect the information of menopause, menarche,
      breast feed, HRT, OCP use and pregnancy. To this end, investigators will contact female
      patients in the database who are still living, and obtain verbal informed consent to send an
      email questionnaire regarding their pregnancy and hormone use history.
observational model: Cohort
time perspective: Other
measure: Time to Pancreatic Neuroendocrine Tumors (PNET)
time frame: 10 years
description: Time to PNET calculated starting from the date of menarche time to the PNET diagnostic date or the menopause date (for the patients who get the menopause prior to the PNET diagnosis) or the last follow-up date.
measure: Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET
time frame: 10 years
description: Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).
arm group label: Participants With Confirmed MEN1 With PNET
description: Retrospective review of a prospectively maintained MEN1 database.
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
arm group label: Participants With Confirmed MEN1 Without PNET
description: Retrospective review of a prospectively maintained MEN1 database.
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
intervention type: Other
intervention name: Chart Review
description: Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.
arm group label: Participants With Confirmed MEN1 With PNET
arm group label: Participants With Confirmed MEN1 Without PNET
intervention type: Behavioral
intervention name: Questionnaire
description: Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
arm group label: Participants With Confirmed MEN1 With PNET
arm group label: Participants With Confirmed MEN1 Without PNET
other name: Survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nancy D. Perrier, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
mesh term: Adenoma, Islet Cell
mesh term: Multiple Endocrine Neoplasia Type 1