Latent Tuberculosis, Tuberculosis, Pulmonary
Conditions
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.
Interventions
RADIATIONUltra low dose chest computed tomography (ULDCT)
Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
RADIATIONChest X-ray
Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
DIAGNOSTIC_TESTInterferon-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.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of active pulmonary tuberculosis | For a year | Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of active pulmonary tuberculosis at enrollment | Baseline | Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update) |
| Prevalence of latent tuberculosis at enrollment | Baseline | Latent tuberculosis defined by guidelines on the management of latent tuberculosis infection |
| Change of ultra low dose chest CT findings in latent tuberculosis patients | Baseline, 3-month follow-up, and 12-month follow-up | Serial comparison analysis of CT findings in latent tuberculosis patients who diagnosed latent tuberculosis based on IFN-gamma assay |
Countries
South Korea
Contacts
Primary ContactJae-Joon Yim, MD, PhD
Outcome results
None listed