Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT to Predict Progression to Active Tuberculosis Among Contacts
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Incidence of active pulmonary tuberculosis
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Vulnerable subjects with mental retardation or severe mental illness
- •Patients who could not receive chest CT
- •Pregnancy
- •Close contacts who diagnosed active pulmonary tuberculosis
研究组 & 干预措施
Close contacts of active pulmonary tuberculosis patients
One arm study of conducting ULDCT, chest x-ray, and IGRA
干预措施: Ultra low dose chest computed tomography (ULDCT) (Radiation)
Close contacts of active pulmonary tuberculosis patients
One arm study of conducting ULDCT, chest x-ray, and IGRA
干预措施: Chest X-ray (Radiation)
Close contacts of active pulmonary tuberculosis patients
One arm study of conducting ULDCT, chest x-ray, and IGRA
干预措施: Interferon-gamma Release Assay (IGRA) (Diagnostic Test)
结局指标
主要结局
Incidence of active pulmonary tuberculosis
时间窗: For a year
Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)
次要结局
- 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)
研究者
Jae-Joon Yim
Professor
Seoul National University Hospital