Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Seoul National University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01121068
First received: May 9, 2010
Last updated: May 11, 2010
Last verified: May 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 9, 2010 | ||||||||
| Last Updated Date | May 11, 2010 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Results of interferon-gamma releasing assay [ Time Frame: monthly for 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01121068 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients | ||||||||
| Official Title ICMJE | Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients | ||||||||
| Brief Summary | 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. |
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| Detailed Description | IGRA will be performed monthly in health-care workers with continuous exposure to tuberculosis patients for 1 year. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Health care workers who are continuously exposed to TB patients |
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| Condition ICMJE | Tuberculosis | ||||||||
| Intervention ICMJE | Other: Blood samplings
About 3.5ml of blood will be drawn from the participants monthly. |
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| Study Group/Cohort (s) | Health care workers
Intervention: Other: Blood samplings |
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| Publications * | 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-γ release assays among health-care workers in contact with patients with TB. Chest. 2012 Dec;142(6):1461-8. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01121068 | ||||||||
| Other Study ID Numbers ICMJE | monthly IGRA | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jae-Joon Yim, Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine | ||||||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Hospital | ||||||||
| Verification Date | May 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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