<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/NCT02231593</url>
  </required_header>
  <id_info>
    <org_study_id>8-79-52030-257</org_study_id>
    <nct_id>NCT02231593</nct_id>
  </id_info>
  <brief_title>SAGIT for Classification of Patients With Acromegaly in Clinical Practice</brief_title>
  <acronym>SAGIT Pilot</acronym>
  <official_title>Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated&#xD;
      comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported&#xD;
      Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will&#xD;
      determine the potential use of a finalised operational version for patient classification in&#xD;
      clinical practice and studies.&#xD;
&#xD;
      In addition, this study intends to carry out a qualitative evaluation of the acceptability of&#xD;
      SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and&#xD;
      usefulness of the tool in practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of acromegaly patients classified using SAGIT</measure>
    <time_frame>8 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Acromegaly</condition>
  <arm_group>
    <arm_group_label>Acromegalic patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SAGIT</intervention_name>
    <description>SAGIT is a Clinician-Reported Outcomes (ClinROs) tool</description>
    <arm_group_label>Acromegalic patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 18 years-old or above&#xD;
&#xD;
          -  Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated&#xD;
             IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)&#xD;
&#xD;
          -  Controlled/stable, active and treatment naïve patients.&#xD;
&#xD;
          -  Patient with the cognitive and linguistic capacities to understand the information&#xD;
             letter of the study&#xD;
&#xD;
          -  Patient who signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of non-compliance or inability to reliably receive treatment in the&#xD;
             foreseeable future&#xD;
&#xD;
          -  Gaps in treatment of greater than 1 month within the 12 months prior to study entry&#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>Ipsen Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NW Pituitary Center and Neurological Surgery</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal University of Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <zip>31270-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Curitiba</city>
        <zip>80210070</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice</name>
      <address>
        <city>Saúde</city>
        <zip>04143020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of São Paulo Medical School</name>
      <address>
        <city>São Paulo</city>
        <zip>01246903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bicetre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Huriez, CHRU DE Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes Hôpital sud</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21</name>
      <address>
        <city>Berlin</city>
        <zip>12159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU München</name>
      <address>
        <city>München</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Spedali Civil di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montichiari Hospital</name>
      <address>
        <city>Montichiari</city>
        <zip>25018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Giovanni Battista Hospital</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Coruna</name>
      <address>
        <city>La Coruna</city>
        <zip>15002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitary Hospital Virgen de la Vitoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds General Infirmary</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</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>Acromegaly</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/NCT02231593
org study id: 8-79-52030-257
nct id: NCT02231593
lead sponsor: 
has dmc: No
The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated
      comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported
      Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will
      determine the potential use of a finalised operational version for patient classification in
      clinical practice and studies.

      In addition, this study intends to carry out a qualitative evaluation of the acceptability of
      SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and
      usefulness of the tool in practice.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of acromegaly patients classified using SAGIT
time frame: 8 months
arm group label: Acromegalic patients
intervention type: Other
intervention name: SAGIT
description: SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
arm group label: Acromegalic patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ipsen Study Director
role: Study Director
affiliation: Ipsen
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country: Brazil
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Acromegaly