Clinical trial NCT03220464: Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT
Official title: Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT to Predict Progression to Active Tuberculosis Among Contacts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis, Pulmonary
Latent Tuberculosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Detailed description: The early diagnosis of active tuberculosis in close contacts have not yet been established. To evaluate the early detection of active pulmonary tuberculosis using ULDCT, the investigators will establish the observational cohort of close contacts living in the same space with active pulmonary tuberculosis. Participants will visit our center at enrollment, after 3 months, and 12 months and will be received ULDCT, chest X-ray and Interferon-gamma assays at each visit. One chest radiologist will interpret findings of ULDCT and chest X-ray.

Patients diagnosed with active tuberculosis will be excluded from the study and treated based on World Health Organization guidelines.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Vulnerable subjects with mental retardation or severe mental illness
* Patients who could not receive chest CT
* Pregnancy
* Close contacts who diagnosed active pulmonary tuberculosis

Primary outcomes:
measure: Incidence of active pulmonary tuberculosis
timeFrame: For a year
Secondary outcomes:
measure: Prevalence of active pulmonary tuberculosis at enrollment
timeFrame: Baseline
measure: Prevalence of latent tuberculosis at enrollment
timeFrame: Baseline
measure: Change of ultra low dose chest CT findings in latent tuberculosis patients
timeFrame: Baseline, 3-month follow-up, and 12-month follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Joon Yim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: World Health Organization, and Stop TB Initiative (World Health Organization). Treatment of tuberculosis: guidelines. World Health Organization, 2010.
citation: Guidelines on the Management of Latent Tuberculosis Infection. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK293818/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.