Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 2:48 AM
Study NCT ID:
NCT01121068
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2010-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017218', 'term': 'Cordocentesis'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-03', 'studyFirstSubmitDate': '2010-05-09', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of interferon-gamma releasing assay', 'timeFrame': 'monthly for 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IGRA', 'variability', 'Long-term variability of IGRA'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '22556318', 'type': 'DERIVED', 'citation': 'Park JS, Lee JS, Kim MY, Lee CH, Yoon HI, Lee SM, Yoo CG, Kim YW, Han SK, Yim JJ. Monthly follow-ups of interferon-gamma release assays among health-care workers in contact with patients with TB. Chest. 2012 Dec;142(6):1461-1468. doi: 10.1378/chest.11-3299.'}]}, 'descriptionModule': {'briefSummary': 'Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis. However,IGRA responses could show within-subject variability. We wanted to determine long-term IGRA variability in health-care workers who continuously expose to tuberculosis patients.', 'detailedDescription': 'IGRA will be performed monthly in health-care workers with continuous exposure to tuberculosis patients for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health care workers who are continuously exposed to TB patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health care workers who are continuously exposed to TB patients Age \\> 20 years\n\nExclusion Criteria:\n\n* Pregnant Active TB Use of immunosuppressants'}, 'identificationModule': {'nctId': 'NCT01121068', 'briefTitle': 'Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients', 'orgStudyIdInfo': {'id': 'monthly IGRA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care workers', 'interventionNames': ['Other: Blood samplings']}], 'interventions': [{'name': 'Blood samplings', 'type': 'OTHER', 'description': 'About 3.5ml of blood will be drawn from the participants monthly.', 'armGroupLabels': ['Health care workers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Joon Yim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Joon Yim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}