Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT
1 other identifier
interventional
116
1 country
1
Brief Summary
The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2017
CompletedFirst Submitted
Initial submission to the registry
June 25, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJuly 21, 2017
July 1, 2017
1.9 years
June 25, 2017
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of active pulmonary tuberculosis
Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)
For a year
Secondary Outcomes (3)
Prevalence of active pulmonary tuberculosis at enrollment
Baseline
Prevalence of latent tuberculosis at enrollment
Baseline
Change of ultra low dose chest CT findings in latent tuberculosis patients
Baseline, 3-month follow-up, and 12-month follow-up
Study Arms (1)
Close contacts of active pulmonary tuberculosis patients
EXPERIMENTALOne arm study of conducting ULDCT, chest x-ray, and IGRA
Interventions
Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
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.
Eligibility Criteria
You may qualify if:
- Close contacts of active pulmonary tuberculosis
- 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.
You may not qualify if:
- Vulnerable subjects with mental retardation or severe mental illness
- Patients who could not receive chest CT
- Pregnancy
- Close contacts who diagnosed active pulmonary tuberculosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (8)
World Health Organization, and Stop TB Initiative (World Health Organization). Treatment of tuberculosis: guidelines. World Health Organization, 2010.
BACKGROUNDGuidelines on the Management of Latent Tuberculosis Infection. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK293818/
PMID: 25973515BACKGROUNDLee 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.
PMID: 19880906RESULTPiccazzo 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.
PMID: 24788998RESULTLew 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.
PMID: 19383198RESULTFujikawa 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.
PMID: 24454900RESULTSloot 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.
PMID: 25265362RESULTFox 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.
PMID: 22936710RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Joon Yim, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 25, 2017
First Posted
July 18, 2017
Study Start
June 20, 2017
Primary Completion
April 30, 2019
Study Completion
April 30, 2020
Last Updated
July 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share