<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/NCT03010111</url>
  </required_header>
  <id_info>
    <org_study_id>HYUMC_CM_001</org_study_id>
    <nct_id>NCT03010111</nct_id>
  </id_info>
  <brief_title>Latent Tuberculosis Infection in Korean Health Care Workers</brief_title>
  <official_title>Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanyang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using&#xD;
      whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean&#xD;
      health care workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Further study details as provided by Hanyang University Hospital&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of latent tuberculosis infection developed in Korean health care workers</measure>
    <time_frame>Three months</time_frame>
    <description>The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test) and blood sampling at enrollment. So, the length of time which from the start of the first test of very first participants to the end of test of very last participant is 3 months. The percentage of participants with LTBI in health care workers was evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Annual incidence of latent tuberculosis infection in Korean health care workers</measure>
    <time_frame>1 year after first QFT-IT test (12-15 months)</time_frame>
    <description>QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of time which from the start of the first test of very first participants to the end of the second test of very last participant is 12 to 15 months. The percentage of participants with positive conversion in follow-up QFT-IT test (second test) was evaluated in participants who had negative results in the first QFT-IT test. Annual infection of LTBI was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Latent Tuberculosis</condition>
  <arm_group>
    <arm_group_label>health care workers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>QFT-IT Test and other blood sampling</intervention_name>
    <description>In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.</description>
    <arm_group_label>health care workers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health care workers in University affiliated hospital&#xD;
&#xD;
          -  Adult aged 20-65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Subjects diagnosed with HIV infection, malignancy&#xD;
&#xD;
          -  Subjects having immunosuppressive drug therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jang Won Shon, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hanyang University Hospital, Seoul, Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dong Won Park, M.D., Ph.D.</last_name>
    <email>portrayme@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jang Won Shon, M.D., Ph.D.</last_name>
      <phone>82-2-2290-8351</phone>
      <email>jwsohn@hanyang.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University</investigator_affiliation>
    <investigator_full_name>Dong Won Park</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Latent Tuberculosis</keyword>
  <keyword>Interferons</keyword>
  <keyword>Tuberculosis</keyword>
  <keyword>Healthcare</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</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/NCT03010111
org study id: HYUMC_CM_001
nct id: NCT03010111
lead sponsor: 
has dmc: Yes
The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using
      whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean
      health care workers.
Further study details as provided by Hanyang University Hospital
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Percentage of latent tuberculosis infection developed in Korean health care workers
time frame: Three months
description: The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test) and blood sampling at enrollment. So, the length of time which from the start of the first test of very first participants to the end of test of very last participant is 3 months. The percentage of participants with LTBI in health care workers was evaluated.
measure: Annual incidence of latent tuberculosis infection in Korean health care workers
time frame: 1 year after first QFT-IT test (12-15 months)
description: QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of time which from the start of the first test of very first participants to the end of the second test of very last participant is 12 to 15 months. The percentage of participants with positive conversion in follow-up QFT-IT test (second test) was evaluated in participants who had negative results in the first QFT-IT test. Annual infection of LTBI was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test.
arm group label: health care workers
arm group type: Other
description: health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital
intervention type: Other
intervention name: QFT-IT Test and other blood sampling
description: In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.
arm group label: health care workers
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jang Won Shon, M.D., Ph.D.
role: Principal Investigator
affiliation: Hanyang University Hospital, Seoul, Korea
last name: Dong Won Park, M.D., Ph.D.
email: portrayme@hanmail.net
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hanyang University
investigator full name: Dong Won Park
investigator title: assistant professor
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
sharing ipd: No