Interstitial Lung Disease Registry Construction
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Paranasal sinus X-ray(PNS series)
研究概览
简要总结
The purpose of this study is investigating the clinical course, treatment course, and prognosis of patients with interstitial lung disease.
详细描述
Interstitial lung disease refers to pulmonary disease that occurs in the interstitium of the lung.
It can be broadly classified into lung disease secondary to the cause of systemic disease or drug, and lung disease whose cause is unknown, and the latter is known as idiopathic interstitial pneumonia.
Idiopathic interstitial pneumonia is a lung disease showing various aspects of inflammatory response and fibrosis reaction, and the cause of the onset is not accurately known yet, also there is no effective treatment.
Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis, progresses very slowly, but sometimes acute exacerbation without any obvious cause leads to death, rapidly.
Therefore, it is important to collect data prospectively for changes in clinical features, pulmonary function, imaging findings, and quality of life of these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years diagnosed with interstitial lung disease
- •Diagnostic criteria for interstitial lung disease. If one of the following is met:
- •clinical suspicion of idiopathic pulmonary fibrosis (IPF); Characteristic chest CT findings with honeycomb cysts and fibrosis and reasonable clinical signs
- •suspected interstitial pneumonia, or confirmed by biopsy with no evidence of infection : IPF, Non-specific interstitial pneumonia(NSIP), Cryptogenic organizing pneumonia(COP), unclassified fibrosis
- •interstitial lung disease suspects with underlying rheumatic disease
排除标准
- •No specific criteria
结局指标
主要结局
Paranasal sinus X-ray(PNS series)
时间窗: at baseline
baseline PNS X-ray
Electrocardiogram(ECG)
时间窗: at baseline
baseline ECG
Chest CT
时间窗: at baseline, every 1 year through study completion for 10 years
monitoring changes in chest radiography
St George's Respiratory Questionnaire(SGRQ)
时间窗: at baseline, every 1 year through study completion for 10 years
monitoring changes in clinical symptoms
modified Medical Research Council (mMRC) dyspnea scale
时间窗: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
monitoring changes in clinical symptoms
Borg dyspnea scale
时间窗: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
monitoring changes in clinical symptoms
Hospital anxiety and depression score(HADS)
时间窗: at baseline, every 1 year through study completion for 10 years
monitoring changes in clinical symptoms
chest X-ray
时间窗: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
monitoring changes in chest radiography
Pulmonary function test with bronchodilator response test(PFT+BDR)
时间窗: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
monitoring changes in lung function
Diffusing capacity of the lungs for carbon monoxide(DLCO)
时间窗: at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years
monitoring changes in lung function
total lung capacity(TLC)
时间窗: at baseline
monitoring changes in lung function
Bronchoscopic alveolar lavage(BAL)
时间窗: at baseline
for diagnostic purposes if necessary
Video-assisted thoracoscopic surgery(VATS) lung biopsy
时间窗: at baseline
for diagnostic purposes if necessary
echocardiography
时间窗: at baseline
additionally tested at acute exacerbation
arterial blood gas analysis(ABGA)
时间窗: at baseline
additionally tested at acute exacerbation
次要结局
未报告次要终点
研究者
Sun Mi Choi
Assistant professor
Seoul National University Hospital