<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/NCT03042026</url>
  </required_header>
  <id_info>
    <org_study_id>201204079RIC</org_study_id>
    <nct_id>NCT03042026</nct_id>
  </id_info>
  <brief_title>Developing a Simple Recognition System of Acromegaly</brief_title>
  <official_title>Developing a Simple Recognition System of Acromegaly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      We will compare the features of 3D stereophotography of acromegaly patients with that of&#xD;
      healthy people. We hope to develop a computerized model to help screening acromegaly patients&#xD;
      for early detection and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Acromegaly is a slowly progressive disease caused by growth hormone (GH) excess.&#xD;
      The estimated prevalence of the disease is 40 cases/1000000 population with 3-4 new&#xD;
      cases/1000000 population per year. Most patients have classic manifestations due to acral and&#xD;
      soft tissue change, including thickening of the calvarium, increased size of frontal sinus,&#xD;
      enlargement of the nose, prognathism, and widely spaced teeth. The hands and feet are large,&#xD;
      thickened and bulky. Acromegaly was also associated with many comorbidities including&#xD;
      cardiovascular complications (acromegalic cardiomyopathy and arterial hypertension),&#xD;
      respiratory complications (sleep apnea), metabolic complication (impaired glucose tolerance,&#xD;
      diabetes mellitus), joint and bone complications (carpal-tunnel syndrome, osteoarthritis).3&#xD;
      The outcome of growth hormone level suppression after transsphenoidal surgery is far better&#xD;
      for microadenomas (80-90%) than for macroadenomas (less than 50%). Furthermore, higher growth&#xD;
      hormone level at diagnosis was related to poor prognosis. An early detection of acromegaly&#xD;
      with early intervention was desirable. However, due to the slowly progression of the disease,&#xD;
      times from symptom onset to diagnosis were 5.2 to 5.9 year4.&#xD;
&#xD;
      Current method to diagnose patients with acromegaly was to check serum GH and insulin-like&#xD;
      growth factor 1 (IGF-1). However, tests for growth hormone and IGF-1 are currently&#xD;
      unavailable in most hospitals in Taiwan and were expensive. We want to find a better&#xD;
      screening tool for acromegaly with less expensive and high efficacy. Due to specific facial&#xD;
      appearance of acromegaly, there were studies to recognize acromegaly by computer&#xD;
      program1,2,3. They tried to develop computer programs to separate facial photographs of&#xD;
      patient with acromegaly and normal subjects. The accuracy could reach 71.9% to 86%. Due to&#xD;
      enlarged hand with increased soft tissue in patients with acromegaly, we also want to compare&#xD;
      the difference of face, hand and feet morphology and face, hand and feet X ray of acromegaly&#xD;
      patients with those of normal population. We hope to set a computer model to early detect&#xD;
      acromegaly patients in Chinese people.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Anticipated">June 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Anthropometry</measure>
    <time_frame>1 year from the first time of 3D stereophotography</time_frame>
    <description>Features of the body including face, hands and feet</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Acromegaly</condition>
  <arm_group>
    <arm_group_label>Acromegaly patients</arm_group_label>
    <description>Acromegaly patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Healthy volunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Acromegaly patients and Healthy Adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-80 years old, Acromegaly patients or Healthy Adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy. Age less than 20 years old or older than 80 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shyang-Rong Shih, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shyang-Rong Shih, PhD</last_name>
    <phone>886-2-23123456</phone>
    <email>srshih@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shyang-Rong Shih, PhD</last_name>
      <phone>2-23123456</phone>
      <email>srshih@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 5, 2017</last_update_submitted>
  <last_update_submitted_qc>February 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</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>
  <patient_data>
    <sharing_ipd>No</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/NCT03042026
org study id: 201204079RIC
nct id: NCT03042026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We will compare the features of 3D stereophotography of acromegaly patients with that of
      healthy people. We hope to develop a computerized model to help screening acromegaly patients
      for early detection and treatment.
Background: Acromegaly is a slowly progressive disease caused by growth hormone (GH) excess.
      The estimated prevalence of the disease is 40 cases/1000000 population with 3-4 new
      cases/1000000 population per year. Most patients have classic manifestations due to acral and
      soft tissue change, including thickening of the calvarium, increased size of frontal sinus,
      enlargement of the nose, prognathism, and widely spaced teeth. The hands and feet are large,
      thickened and bulky. Acromegaly was also associated with many comorbidities including
      cardiovascular complications (acromegalic cardiomyopathy and arterial hypertension),
      respiratory complications (sleep apnea), metabolic complication (impaired glucose tolerance,
      diabetes mellitus), joint and bone complications (carpal-tunnel syndrome, osteoarthritis).3
      The outcome of growth hormone level suppression after transsphenoidal surgery is far better
      for microadenomas (80-90%) than for macroadenomas (less than 50%). Furthermore, higher growth
      hormone level at diagnosis was related to poor prognosis. An early detection of acromegaly
      with early intervention was desirable. However, due to the slowly progression of the disease,
      times from symptom onset to diagnosis were 5.2 to 5.9 year4.

      Current method to diagnose patients with acromegaly was to check serum GH and insulin-like
      growth factor 1 (IGF-1). However, tests for growth hormone and IGF-1 are currently
      unavailable in most hospitals in Taiwan and were expensive. We want to find a better
      screening tool for acromegaly with less expensive and high efficacy. Due to specific facial
      appearance of acromegaly, there were studies to recognize acromegaly by computer
      program1,2,3. They tried to develop computer programs to separate facial photographs of
      patient with acromegaly and normal subjects. The accuracy could reach 71.9% to 86%. Due to
      enlarged hand with increased soft tissue in patients with acromegaly, we also want to compare
      the difference of face, hand and feet morphology and face, hand and feet X ray of acromegaly
      patients with those of normal population. We hope to set a computer model to early detect
      acromegaly patients in Chinese people.
observational model: Case-Control
time perspective: Prospective
measure: Anthropometry
time frame: 1 year from the first time of 3D stereophotography
description: Features of the body including face, hands and feet
arm group label: Acromegaly patients
description: Acromegaly patients
arm group label: Healthy subjects
description: Healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shyang-Rong Shih, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Shyang-Rong Shih, PhD
phone: 886-2-23123456
email: srshih@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Acromegaly
sharing ipd: No