Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT
NCT ID: NCT03220464
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2017-06-20
2020-04-30
Brief Summary
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Detailed Description
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Patients diagnosed with active tuberculosis will be excluded from the study and treated based on World Health Organization guidelines.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Close contacts of active pulmonary tuberculosis patients
One arm study of conducting ULDCT, chest x-ray, and IGRA
Ultra low dose chest computed tomography (ULDCT)
Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
Chest X-ray
Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
Interferon-gamma Release Assay (IGRA)
Participants in the study will receive IGRA test at enrollment, after 3-month visit, and after 12-month visit. About 11mL of blood will be drawn from the participants for test of T-SPOT®.TB test and QuantiFERON test.
Interventions
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Ultra low dose chest computed tomography (ULDCT)
Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
Chest X-ray
Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
Interferon-gamma Release Assay (IGRA)
Participants in the study will receive IGRA test at enrollment, after 3-month visit, and after 12-month visit. About 11mL of blood will be drawn from the participants for test of T-SPOT®.TB test and QuantiFERON test.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Family members of active TB patient who has lived together for more than one month, or work colleagues of active TB patient who has been working in the same office for more than 8 months
* Participants who received explanation of the research plan, understands and writes agreement.
Exclusion Criteria
* Patients who could not receive chest CT
* Pregnancy
* Close contacts who diagnosed active pulmonary tuberculosis
18 Years
80 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jae-Joon Yim
Professor
Principal Investigators
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Jae-Joon Yim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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World Health Organization, and Stop TB Initiative (World Health Organization). Treatment of tuberculosis: guidelines. World Health Organization, 2010.
Guidelines on the Management of Latent Tuberculosis Infection. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK293818/
Lee SW, Jang YS, Park CM, Kang HY, Koh WJ, Yim JJ, Jeon K. The role of chest CT scanning in TB outbreak investigation. Chest. 2010 May;137(5):1057-64. doi: 10.1378/chest.09-1513. Epub 2009 Oct 31.
Piccazzo R, Paparo F, Garlaschi G. Diagnostic accuracy of chest radiography for the diagnosis of tuberculosis (TB) and its role in the detection of latent TB infection: a systematic review. J Rheumatol Suppl. 2014 May;91:32-40. doi: 10.3899/jrheum.140100.
Lew WJ, Jung YJ, Song JW, Jang YM, Kim HJ, Oh YM, Lee SD, Kim WS, Kim DS, Kim WD, Shim TS. Combined use of QuantiFERON-TB Gold assay and chest computed tomography in a tuberculosis outbreak. Int J Tuberc Lung Dis. 2009 May;13(5):633-9.
Fujikawa A, Fujii T, Mimura S, Takahashi R, Sakai M, Suzuki S, Kyoto Y, Uwabe Y, Maeda S, Mori T. Tuberculosis contact investigation using interferon-gamma release assay with chest x-ray and computed tomography. PLoS One. 2014 Jan 14;9(1):e85612. doi: 10.1371/journal.pone.0085612. eCollection 2014.
Sloot R, Schim van der Loeff MF, Kouw PM, Borgdorff MW. Risk of tuberculosis after recent exposure. A 10-year follow-up study of contacts in Amsterdam. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1044-52. doi: 10.1164/rccm.201406-1159OC.
Fox GJ, Barry SE, Britton WJ, Marks GB. Contact investigation for tuberculosis: a systematic review and meta-analysis. Eur Respir J. 2013 Jan;41(1):140-56. doi: 10.1183/09031936.00070812. Epub 2012 Aug 30.
Other Identifiers
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1704-157-849
Identifier Type: -
Identifier Source: org_study_id
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