<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/NCT02190214</url>
  </required_header>
  <id_info>
    <org_study_id>MyEndo-Thyroid</org_study_id>
    <nct_id>NCT02190214</nct_id>
  </id_info>
  <brief_title>Thyroid Disorders in Malaysia: A Nationwide Multicentre Study</brief_title>
  <acronym>MyEndo-Thyroid</acronym>
  <official_title>Thyroid Disorders in Malaysian: A Nationwide Multicentre Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Islamic University Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Malaysian Endocrine and Metabolic Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National University of Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Islamic University Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a population based study looking at the prevalence of thyroid disorders in&#xD;
      Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its&#xD;
      association with different ethnicity and iodine status. The study will also look at genetic&#xD;
      susceptibility for autoimmune thyroid disorders in the Malaysian population&#xD;
&#xD;
      General hypotheses:&#xD;
&#xD;
      The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for&#xD;
      hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population&#xD;
      There are different susceptibility gene for autoimmune thyroid disorder in different&#xD;
      ethnicity in our population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a cross-sectional population based study involving Malaysian adults (aged 18&#xD;
      year old and above). Cluster sampling will be used to select respondents that will be&#xD;
      representative of the Malaysian population. Selected respondent will be interviewed,&#xD;
      anthropometric measurement taken, blood and urine sample taken.&#xD;
&#xD;
      Blood will be analyzed for thyroid function (thyroxine, triiodothyronine and thyroid&#xD;
      stimulating hormone), autoantibodies (anti-thyroperoxidase and anti-thyroglobulin). Urine&#xD;
      will be analyzed for urinary iodine.&#xD;
&#xD;
      Those diagnosed with autoimmune thyroid disorders with strong family history of thyroid&#xD;
      disorders (multiplex multi-generation family involvement) will have their blood sent for&#xD;
      whole exome sequencing and linkage analysis done to identify possible susceptible gene for&#xD;
      autoimmune thyroid disorders&#xD;
&#xD;
      Respondents detected to have hypo- or hyper- and subclinical hypo- or hyperthyroidism will be&#xD;
      referred to their nearest health centre for further evaluation and treatment appropriate for&#xD;
      their condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with abnormal thyroid function</measure>
    <time_frame>Day 0</time_frame>
    <description>Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with positive thyroid autoantibodies</measure>
    <time_frame>Day 0</time_frame>
    <description>Anti-thyroglobulin Anti-thyroperoxidase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Iodine deficiency status</measure>
    <time_frame>Day 0</time_frame>
    <description>Urinary iodine level</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with genetic susceptibility to autoimmune thyroid disorders</measure>
    <time_frame>Day 0</time_frame>
    <description>whole exome sequencing and linkage analysis in families with autoimmune thyroid disorders (multiplex multi-generation involvement)</description>
  </other_outcome>
  <enrollment type="Actual">2498</enrollment>
  <condition>Hypothyroidism</condition>
  <condition>Subclinical Hypothyroidism</condition>
  <condition>Hyperthyroidism</condition>
  <condition>Subclinical Hyperthyroidism</condition>
  <condition>Graves Disease</condition>
  <condition>Hashimoto's Thyroiditis</condition>
  <condition>Iodine Deficiency</condition>
  <condition>Genetic Susceptibility</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole Blood Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult (aged equal or more than 18 years old ) Malaysian citizen living in Malaysia at the&#xD;
        time of sampling&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged equal or more than 18 years old at the time of sampling&#xD;
&#xD;
          -  Malaysian citizen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Respondents who did not give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nor Azmi Kamaruddin, MBBS, MMed</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norlela Sukor, MMed, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norhanita Othman</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Johari Ali</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shirenee Vethakkan</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Siew Kim Kwa</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kuck Meng Chong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lecthuman Ramanathan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hussein Zanariah</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nurain Mohd Noor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norhaliza Mohd Ali</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norhayati Yahya</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nor Azizah Aziz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysian Endocrine and Metabolic Society</affiliation>
  </overall_official>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>October 17, 2016</last_update_submitted>
  <last_update_submitted_qc>October 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Islamic University Malaysia</investigator_affiliation>
    <investigator_full_name>Dr Mohamnmad Arif Shahar</investigator_full_name>
    <investigator_title>Assist Prof</investigator_title>
  </responsible_party>
  <keyword>Hyperthyroidism</keyword>
  <keyword>Hypothyroidism</keyword>
  <keyword>Autoimmune thyroid disorders</keyword>
  <keyword>Iodine deficiency</keyword>
  <keyword>Genetic susceptibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graves Disease</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Hypothyroidism</mesh_term>
    <mesh_term>Hyperthyroidism</mesh_term>
    <mesh_term>Thyroiditis</mesh_term>
    <mesh_term>Hashimoto Disease</mesh_term>
    <mesh_term>Disease Susceptibility</mesh_term>
    <mesh_term>Genetic Predisposition to Disease</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/NCT02190214
org study id: MyEndo-Thyroid
nct id: NCT02190214
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This will be a population based study looking at the prevalence of thyroid disorders in
      Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its
      association with different ethnicity and iodine status. The study will also look at genetic
      susceptibility for autoimmune thyroid disorders in the Malaysian population

      General hypotheses:

      The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for
      hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population
      There are different susceptibility gene for autoimmune thyroid disorder in different
      ethnicity in our population
This will be a cross-sectional population based study involving Malaysian adults (aged 18
      year old and above). Cluster sampling will be used to select respondents that will be
      representative of the Malaysian population. Selected respondent will be interviewed,
      anthropometric measurement taken, blood and urine sample taken.

      Blood will be analyzed for thyroid function (thyroxine, triiodothyronine and thyroid
      stimulating hormone), autoantibodies (anti-thyroperoxidase and anti-thyroglobulin). Urine
      will be analyzed for urinary iodine.

      Those diagnosed with autoimmune thyroid disorders with strong family history of thyroid
      disorders (multiplex multi-generation family involvement) will have their blood sent for
      whole exome sequencing and linkage analysis done to identify possible susceptible gene for
      autoimmune thyroid disorders

      Respondents detected to have hypo- or hyper- and subclinical hypo- or hyperthyroidism will be
      referred to their nearest health centre for further evaluation and treatment appropriate for
      their condition.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Number of participants with abnormal thyroid function
time frame: Day 0
description: Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism
measure: Number of participants with positive thyroid autoantibodies
time frame: Day 0
description: Anti-thyroglobulin Anti-thyroperoxidase
measure: Number of participants with Iodine deficiency status
time frame: Day 0
description: Urinary iodine level
measure: Number of participants with genetic susceptibility to autoimmune thyroid disorders
time frame: Day 0
description: whole exome sequencing and linkage analysis in families with autoimmune thyroid disorders (multiplex multi-generation involvement)
Whole Blood Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nor Azmi Kamaruddin, MBBS, MMed
role: Principal Investigator
affiliation: National University of Malaysia
last name: Norlela Sukor, MMed, Phd
role: Principal Investigator
affiliation: National University of Malaysia
last name: Norhanita Othman
role: Principal Investigator
affiliation: National University of Malaysia
last name: Johari Ali
role: Principal Investigator
affiliation: University of Malaya
last name: Shirenee Vethakkan
role: Principal Investigator
affiliation: University of Malaya
last name: Siew Kim Kwa
role: Principal Investigator
affiliation: International Medical University
last name: Kuck Meng Chong, MD
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
last name: Lecthuman Ramanathan
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
last name: Hussein Zanariah
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
last name: Nurain Mohd Noor
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
last name: Norhaliza Mohd Ali
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
last name: Norhayati Yahya
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
last name: Nor Azizah Aziz
role: Principal Investigator
affiliation: Malaysian Endocrine and Metabolic Society
responsible party type: Principal Investigator
investigator affiliation: International Islamic University Malaysia
investigator full name: Dr Mohamnmad Arif Shahar
investigator title: Assist Prof
mesh term: Graves Disease
mesh term: Thyroid Diseases
mesh term: Hypothyroidism
mesh term: Hyperthyroidism
mesh term: Thyroiditis
mesh term: Hashimoto Disease
mesh term: Disease Susceptibility
mesh term: Genetic Predisposition to Disease