Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-05 @ 5:56 PM
Study NCT ID:
NCT02073669
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2014-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059425', 'term': 'Interferon-gamma Release Tests'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2014-02-26', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interferon gamma release assay ( IGRA)', 'timeFrame': 'Up to 3 months after tuberculin skin test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['latent tuberculosis', 'tuberculin skin test', 'Interferon gamma release assay', 'immigration'], 'conditions': ['Latent Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-25\n* Men and women\n* Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000).\n* Native Israelis without a family member who was born in a country with high incidence of tuberculosis.\n\nExclusion Criteria:\n\n* Prior contact with a tuberculosis patient\n* Working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis.\n* HIV infection and any immunodeficiency condition.\n* Recent live-virus vaccination\n* Acute infectious disease\n* Prior serious reaction to tuberculin skin test\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02073669', 'briefTitle': 'Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Better Identification of Latent Tuberculosis Infection Among Israeli Young Adults by Comparison Skin Tests and Interferon Gamma Releasing Assays (IGRA)', 'orgStudyIdInfo': {'id': 'SHEBA-13-0668-DS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Second generation immigrants from high TB incidence countries', 'description': 'Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).', 'interventionNames': ['Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)']}, {'type': 'OTHER', 'label': 'Native Israelis', 'description': 'Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA).', 'interventionNames': ['Procedure: Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)']}], 'interventions': [{'name': 'Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)', 'type': 'PROCEDURE', 'armGroupLabels': ['Native Israelis', 'Second generation immigrants from high TB incidence countries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Israeli Defense Forces', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tel Aviv Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}