<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/NCT03043586</url>
  </required_header>
  <id_info>
    <org_study_id>AAAQ6709</org_study_id>
    <nct_id>NCT03043586</nct_id>
  </id_info>
  <brief_title>Treatment Patterns and Treatment Outcomes for Acromegaly</brief_title>
  <official_title>Treatment Patterns and Treatment Outcomes in a New York City Based Cohort of 520 Patients With Acromegaly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</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 human, prospective and retrospective, single-center study of patients who have&#xD;
      undergone treatment for acromegaly in New York City since 1981. The project will&#xD;
      characterize, among other factors, the treatment methods received by patients, who&#xD;
      administered the treatments and the success of this therapy in terms of biochemical control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first phase of this study will be to contact all subjects in the cohort by a mailing&#xD;
      introducing them to the study. This will be followed by a phone call and administration of a&#xD;
      questionnaire by phone or by mail. The questionnaire will collect current information on&#xD;
      acromegaly treatment, morbidities other relevant history. Subjects will provide verbal&#xD;
      consent to participate in this questionnaire part of the study and review of their medical&#xD;
      records by the Principal Investigator (PI) and study staff.&#xD;
&#xD;
      In the second phase of the study, subjects will be invited to come for a visit that will be&#xD;
      conducted by the PI and study staff at the Pituitary Center of Columbia University Irving&#xD;
      Medical Center. At this visit written informed consent will be obtained. The investigators&#xD;
      will review the subjects' medical history that is obtained from the subject and review any&#xD;
      records and laboratory test results provided by the subject and conduct clinical and&#xD;
      laboratory assessments. Although all subjects participating in Phase 1 will be invited to&#xD;
      participate, it is estimated that 120 of the subjects invited will come for the one visit&#xD;
      over the 2-year time frame of this study.&#xD;
&#xD;
      In the third phase of the study a chart review for collection will be conducted and all data&#xD;
      will be compiled. All subjects agreeing to participate, both in person and by mail, a chart&#xD;
      review of all relevant patient data including demographic, clinical, biochemical, surgical&#xD;
      and follow up information. Data from questionnaires and record reviews will be compiled for&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 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>Percentage of patients that have received surgery as first line therapy</measure>
    <time_frame>At 5 years of therapy</time_frame>
    <description>Frequency of each type of acromegaly therapy and rates of treatment by surgery alone, somatostatin analog, pegvisomant, radiotherapy and combinations of each of these therapies in the cohort will be recorded and determined. The expected result is that more than 90% of our cohort has received surgery as first line therapy and only a minority has received primary medical therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with IGF-1 levels remaining elevated</measure>
    <time_frame>At 5 years of therapy</time_frame>
    <description>This is to identify patients who are not optimally managed since their IGF-1 levels remain elevated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension Rate</measure>
    <time_frame>At 5 years of therapy</time_frame>
    <description>This is to identify if hypertension is affected by how treatment is managed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Mellitus Rate</measure>
    <time_frame>At 5 years of therapy</time_frame>
    <description>This is to identify if diabetes mellitus is affected by how treatment is managed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Apnea Rate</measure>
    <time_frame>At 5 years of therapy</time_frame>
    <description>This is to identify if sleep apnea is affected by how treatment is managed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">520</enrollment>
  <condition>Acromegaly</condition>
  <arm_group>
    <arm_group_label>Treatment Pattern</arm_group_label>
    <description>The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. A phone script will be utilized to obtain verbal informed consent from subjects for this phase of the study. The questionnaire will collect current information on acromegaly treatment, morbidities and other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the PI and study staff.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood will be sampled for fasting measurements of growth hormone (GH) and insulin Growth&#xD;
      Factor 1 (IGF-1) and patients will undergo an oral glucose tolerance test (OGTT) with blood&#xD;
      drawn before and 60, 90 and 120 minutes after a 75 g. dextrose drink.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population for this study is a cohort of 520 adult patients who have undergone&#xD;
        treatment for acromegaly in NYC since 1981. The cohort is predetermined based on the&#xD;
        patients who have previously undergone pituitary surgery for acromegaly with our two&#xD;
        collaborating Neurosurgeons. Based on prior studies, the population has no gender&#xD;
        predilection and no racial or ethnic predisposition and thus the ethnic mix of the cohort&#xD;
        reflects the population of the NY metropolitan area that is referred to the study center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females.&#xD;
&#xD;
          -  Ages 18 and over.&#xD;
&#xD;
          -  Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.&#xD;
&#xD;
          -  Must be an Acromegaly subject that have undergone Pituitary surgery with Dr. Bruce or&#xD;
             Dr. Post or Present it to principal investigator Dr. Pamela Freda at the&#xD;
             Neuroendocrine Unit at Columbia University Medical Center for evaluation of&#xD;
             Acromegaly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are unwilling to comply with the procedures outlined in the study.&#xD;
&#xD;
          -  Subjects who do not have the ability to fully comprehend the nature of the study, to&#xD;
             follow instructions, and/or cooperate with study procedures.&#xD;
&#xD;
          -  Not being treated for acromegaly either by Dr. Bruce, Dr. Post or Dr. Freda.&#xD;
&#xD;
          -  Are unwilling to provide informed consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela U Freda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neuroendocrine Unit at Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Pamela U. Freda</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Acromegaly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acromegaly</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03043586
org study id: AAAQ6709
nct id: NCT03043586
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a human, prospective and retrospective, single-center study of patients who have
      undergone treatment for acromegaly in New York City since 1981. The project will
      characterize, among other factors, the treatment methods received by patients, who
      administered the treatments and the success of this therapy in terms of biochemical control.
The first phase of this study will be to contact all subjects in the cohort by a mailing
      introducing them to the study. This will be followed by a phone call and administration of a
      questionnaire by phone or by mail. The questionnaire will collect current information on
      acromegaly treatment, morbidities other relevant history. Subjects will provide verbal
      consent to participate in this questionnaire part of the study and review of their medical
      records by the Principal Investigator (PI) and study staff.

      In the second phase of the study, subjects will be invited to come for a visit that will be
      conducted by the PI and study staff at the Pituitary Center of Columbia University Irving
      Medical Center. At this visit written informed consent will be obtained. The investigators
      will review the subjects' medical history that is obtained from the subject and review any
      records and laboratory test results provided by the subject and conduct clinical and
      laboratory assessments. Although all subjects participating in Phase 1 will be invited to
      participate, it is estimated that 120 of the subjects invited will come for the one visit
      over the 2-year time frame of this study.

      In the third phase of the study a chart review for collection will be conducted and all data
      will be compiled. All subjects agreeing to participate, both in person and by mail, a chart
      review of all relevant patient data including demographic, clinical, biochemical, surgical
      and follow up information. Data from questionnaires and record reviews will be compiled for
      analysis.
observational model: Cohort
time perspective: Retrospective
measure: Percentage of patients that have received surgery as first line therapy
time frame: At 5 years of therapy
description: Frequency of each type of acromegaly therapy and rates of treatment by surgery alone, somatostatin analog, pegvisomant, radiotherapy and combinations of each of these therapies in the cohort will be recorded and determined. The expected result is that more than 90% of our cohort has received surgery as first line therapy and only a minority has received primary medical therapy.
measure: Number of patients with IGF-1 levels remaining elevated
time frame: At 5 years of therapy
description: This is to identify patients who are not optimally managed since their IGF-1 levels remain elevated.
measure: Hypertension Rate
time frame: At 5 years of therapy
description: This is to identify if hypertension is affected by how treatment is managed.
measure: Diabetes Mellitus Rate
time frame: At 5 years of therapy
description: This is to identify if diabetes mellitus is affected by how treatment is managed.
measure: Sleep Apnea Rate
time frame: At 5 years of therapy
description: This is to identify if sleep apnea is affected by how treatment is managed.
arm group label: Treatment Pattern
description: The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. A phone script will be utilized to obtain verbal informed consent from subjects for this phase of the study. The questionnaire will collect current information on acromegaly treatment, morbidities and other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the PI and study staff.
Blood will be sampled for fasting measurements of growth hormone (GH) and insulin Growth
      Factor 1 (IGF-1) and patients will undergo an oral glucose tolerance test (OGTT) with blood
      drawn before and 60, 90 and 120 minutes after a 75 g. dextrose drink.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pamela U Freda, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Pamela U. Freda
investigator title: Professor of Medicine
mesh term: Acromegaly
sharing ipd: Undecided