跳至主要内容
临床试验/NCT03238989
NCT03238989
Unknown
不适用

Interstitial Lung Disease Registry Construction

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 300 人2014年1月5日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Interstitial Lung Disease
发起方
Seoul National University Hospital
入组人数
300
试验地点
1
主要终点
Paranasal sinus X-ray(PNS series)
最后更新
8年前

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. A prospective study of idiopathic interstitial pneumonia will provide important information on the clinical characteristics and admission history of patients with idiopathic interstitial pneumonia, and the idiopathic interstitial pneumonia registry system will serve as the basis for further prospective observational studies. The aim of this study is to establish the registry of patients with interstitial lung disease and to prospectively review the clinical features and progression of the patients.

注册库
clinicaltrials.gov
开始日期
2014年1月5日
结束日期
2023年12月31日
最后更新
8年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Sun Mi Choi

Assistant professor

Seoul National University Hospital

入排标准

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

研究点 (1)

Loading locations...

相似试验