<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/NCT01685905</url>
  </required_header>
  <id_info>
    <org_study_id>TST_IGRA</org_study_id>
    <nct_id>NCT01685905</nct_id>
  </id_info>
  <brief_title>The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection</brief_title>
  <official_title>Evaluation of the Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Mycobacterium Tuberculosis Infection in Korean Patients With Rheumatic Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hanyang University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study&#xD;
&#xD;
        1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G),&#xD;
           and determine the level of agreement between two tests in patients with rheumatic&#xD;
           diseases&#xD;
&#xD;
        2. to evaluate the difference in the occurrence of active TB in patients who receive both&#xD;
           QFT-G and TST compared with those who receive only TST for detecting of Latent&#xD;
           tuberculosis infection(LTBI) who are candidates of TNF inhibitors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Assessment&#xD;
&#xD;
        1. The positive rates of QFT-G and TST as a screening test for LTBI&#xD;
&#xD;
             -  The positive rates of QFT-G and TST will be analyzed&#xD;
&#xD;
             -  Additional analysis will be performed according to the type of disease&#xD;
&#xD;
        2. The agreement between QFT-G and TST as a screening test for LTBI&#xD;
&#xD;
             -  The agreement between QFT-G and TST will be analyzed for patients with rheumatic&#xD;
                diseases who examined both QFT-G and TST&#xD;
&#xD;
             -  Additional analysis will be performed according to the type of disease&#xD;
&#xD;
        3. The correlation of the occurrence of active TB and two tests (QFT-G and TST)&#xD;
&#xD;
             -  The analysis of the correlation of the occurrence of active TB and two tests will&#xD;
                be conducted for patients who have experienced anti-TNF agents&#xD;
&#xD;
      3-1. The occurrence of active TB in accordance with results of TST&#xD;
&#xD;
      3-2. The occurrence of active TB in accordance with results of QFT-G&#xD;
&#xD;
      3-3. The difference in the occurrence of active TB in patients performed both QFT-G and TST&#xD;
      compared with those performed only TST for detecting of LTBI who are candidates of TNF&#xD;
      inhibitors (pilot study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Rheumatic Disease</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Tuberculosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        1) Estimation of the positive rates and agreement between QFT-G and TST&#xD;
&#xD;
          -  Approximately 2,000 patients with rheumatic diseases who examined TST or QFT-G in&#xD;
             Hanyang university hospital from 2004 to 2010 2) Determining the difference in the&#xD;
             occurrence of active TB in the TNF inhibitor user according to the screening and the&#xD;
             treatment of LTBI.&#xD;
&#xD;
          -  Approximately 400 patients with rheumatic diseases who received TST or QFT-G before&#xD;
             using anti-TNF agents in Hanyang university hospital from 2004 to 2010&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with rheumatic diseases who examined TST or QFT-G in Hanyang university&#xD;
             hospital from 2004 to 2010&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-cheol Bae, director</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hanyang University Hospital for Rheumatic Disease</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sang-cheol Bae, director</last_name>
    <phone>82-2-2290-8260</phone>
    <email>scbae@hanyang.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang University Hospital for rheumatic disease</name>
      <address>
        <city>Seoul</city>
        <state>Sung-dong Gu</state>
        <zip>133-792</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang-cheol Bae, MD</last_name>
      <phone>82-2-2290-9230</phone>
      <email>scbae@hanyang.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University</investigator_affiliation>
    <investigator_full_name>Sang-Cheol Bae</investigator_full_name>
    <investigator_title>Professor, MD, PhD, MPH</investigator_title>
  </responsible_party>
  <keyword>rheumatic disease, latent tuberculosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Latent Tuberculosis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</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/NCT01685905
org study id: TST_IGRA
nct id: NCT01685905
lead sponsor: 
collaborator: 
has dmc: No
The purposes of this study

        1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G),
           and determine the level of agreement between two tests in patients with rheumatic
           diseases

        2. to evaluate the difference in the occurrence of active TB in patients who receive both
           QFT-G and TST compared with those who receive only TST for detecting of Latent
           tuberculosis infection(LTBI) who are candidates of TNF inhibitors.
Study Assessment

        1. The positive rates of QFT-G and TST as a screening test for LTBI

             -  The positive rates of QFT-G and TST will be analyzed

             -  Additional analysis will be performed according to the type of disease

        2. The agreement between QFT-G and TST as a screening test for LTBI

             -  The agreement between QFT-G and TST will be analyzed for patients with rheumatic
                diseases who examined both QFT-G and TST

             -  Additional analysis will be performed according to the type of disease

        3. The correlation of the occurrence of active TB and two tests (QFT-G and TST)

             -  The analysis of the correlation of the occurrence of active TB and two tests will
                be conducted for patients who have experienced anti-TNF agents

      3-1. The occurrence of active TB in accordance with results of TST

      3-2. The occurrence of active TB in accordance with results of QFT-G

      3-3. The difference in the occurrence of active TB in patients performed both QFT-G and TST
      compared with those performed only TST for detecting of LTBI who are candidates of TNF
      inhibitors (pilot study).
observational model: Cohort
time perspective: Retrospective
measure: The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)
time frame: one year
measure: The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))
time frame: one year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sang-cheol Bae, director
role: Principal Investigator
affiliation: Hanyang University Hospital for Rheumatic Disease
last name: Sang-cheol Bae, director
phone: 82-2-2290-8260
email: scbae@hanyang.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hanyang University
investigator full name: Sang-Cheol Bae
investigator title: Professor, MD, PhD, MPH
mesh term: Tuberculosis
mesh term: Spondylitis
mesh term: Latent Tuberculosis
mesh term: Spondylitis, Ankylosing
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases