Japanese Idiopathic Interstitial Pneumonias Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 867
- 试验地点
- 86
- 主要终点
- Data on current practice patterns for diagnosis of IIPs
研究概览
简要总结
An objective of JIPS Registry is to examine disease behavior of idiopathic interstitial pneumonias (IIPs), considering classification, background, and diagnostic methods based on American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the ATS/ERS classification of 2002 and 2013.
详细描述
JIPS Registry is a multi-site, non-interventional, prospective observation study of patients with newly diagnosed IIPs in Japan. At least 600 patients will be registered for 16 months at approximately 80 sites in Japan.
Primary research question is to determine the natural history of each category of IIPs at registration, patient background and diagnosis methods will be considered. Furthermore, the present treatment patterns and disease behavior (CT and forced vital capacity (FVC) changes, as well as changes in interstitial pneumonia markers, etc.) will also be investigated.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 84 years
- •Patients with idiopathic pulmonary fibrosis (IPF) and other IIPs diagnosis within 6 months before registration at each facility
- •Patients from whom written informed consent has been obtained regarding participation in this study and follow-up observation
排除标准
- •Patients for whom the tests (such as the lung function test) conducted in this study could not be performed
- •Patients who underwent pulmonary resection
- •Patients undergoing dialysis
- •Patients with cancer treated at the time of registration or those planning to receive treatment in the future
结局指标
主要结局
Data on current practice patterns for diagnosis of IIPs
时间窗: 3-4 years
Describe the frequency of surgical lung biopsy, bronchoalveolar lavage.
Prevalence of each categorized IIPs
时间窗: 3-4 years
Investigate the prevalence of each categorized IIPs by using a recent guideline
Natural history of each categorized IIPs
时间窗: 3-4 years
Describe the natural history of each categorized IIPs, focusing on CT findings, FVC changes, medications, and causes of death.
次要结局
- Hospital admission for acute exacerbations of IIPs(3-6 years)
- Quantitative evaluation of CT findings(3-6 years)
- Validation of second multidisciplinary discussion(3-4 years)
- Progression-free survival by category of IIPs(3-6 years)
- Mean change of patient-reported outcome (Saint George Respiratory Questionnaire, COPD assessment test, and Dyspnoea-12) every12 months from baseline(3-4 years)
- Validation of new guideline(3-6 years)
- Diagnosis of IIPs in patients with IIPs at registration(At registration and 1 year after registration)