Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01685905
Status:
UNKNOWN
Last Update Posted:
2012-09-18
First Post:
2012-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-17', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rheumatic disease, latent tuberculosis'], 'conditions': ['Rheumatic Disease', 'Rheumatoid Arthritis', 'Ankylosing Spondylitis', 'Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The purposes of this study\n\n1. 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\n2. 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.', 'detailedDescription': 'Study Assessment\n\n1. The positive rates of QFT-G and TST as a screening test for LTBI\n\n * The positive rates of QFT-G and TST will be analyzed\n * Additional analysis will be performed according to the type of disease\n2. The agreement between QFT-G and TST as a screening test for LTBI\n\n * The agreement between QFT-G and TST will be analyzed for patients with rheumatic diseases who examined both QFT-G and TST\n * Additional analysis will be performed according to the type of disease\n3. The correlation of the occurrence of active TB and two tests (QFT-G and TST)\n\n * 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\n\n3-1. The occurrence of active TB in accordance with results of TST\n\n3-2. The occurrence of active TB in accordance with results of QFT-G\n\n3-3. 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1\\) Estimation of the positive rates and agreement between QFT-G and TST\n\n* Approximately 2,000 patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010 2) Determining the difference in the occurrence of active TB in the TNF inhibitor user according to the screening and the treatment of LTBI.\n* Approximately 400 patients with rheumatic diseases who received TST or QFT-G before using anti-TNF agents in Hanyang university hospital from 2004 to 2010', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01685905', 'briefTitle': 'The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TST_IGRA'}}, 'contactsLocationsModule': {'locations': [{'zip': '133-792', 'city': 'Seoul', 'state': 'Sung-dong Gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-cheol Bae, MD', 'role': 'CONTACT', 'email': 'scbae@hanyang.ac.kr', 'phone': '82-2-2290-9230'}], 'facility': 'Hanyang University Hospital for rheumatic disease', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang-cheol Bae, director', 'role': 'CONTACT', 'email': 'scbae@hanyang.ac.kr', 'phone': '82-2-2290-8260'}], 'overallOfficials': [{'name': 'Sang-cheol Bae, director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University Hospital for Rheumatic Disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD, MPH', 'investigatorFullName': 'Sang-Cheol Bae', 'investigatorAffiliation': 'Hanyang University'}}}}