A Prospective Multi-center Registry for Fibrotic Lung Disease, Focusing on Clinical Phenotype, Physical Parameters, Image Analysis, and Precision Medicine in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
The Taiwan Interstitial Lung Disease (ILD) Multi-center Investigation and Registry aims to evaluate the long-term outcomes of patients with fibrotic interstitial lung disease. This prospective observational registry will collect comprehensive clinical data from multiple centers, including epidemiological information, comorbidities, questionnaire results, routine blood tests, biochemical tests, pulmonary function tests, echocardiograms, and cardiopulmonary exercise tests (CPET), all following a standardized protocol.
Key components of the registry include annual HRCT scans, annual CPETs, biobank blood samples, and biannual echocardiograms and pulmonary function tests.
The main questions the registry aims to answer are:
- Differences in all-cause mortality among ILD patients of different etiologies.
- Differences in the annual risk of acute exacerbation among ILD patients of different etiologies.
- Effectiveness of current anti-fibrotic drugs in treating IPF and ILD of different etiologies.
- Predictive ability of HRCT imaging features for mortality risk in ILD patients.
- Impact of comorbidities on the mortality risk of ILD patients.
- Predictive ability of biomarkers for disease progression and mortality.
详细描述
The goal of this prospective observational registry is to evaluate the long-term outcomes of patients diagnosed with fibrotic interstitial lung disease in Taiwan.
The investigators will conduct a prospective registry and collect clinical data of fibrotic lung disease patients from multiple centers in Taiwan. The data collected will include basic epidemiological information, comorbidities, questionnaire results, routine blood tests, biochemical tests, pulmonary function tests, echocardiograms, and cardiopulmonary exercise tests (CPET). Each hospital will follow the same protocol for data collection, establishing a real-world Taiwan Fibrotic Lung Disease Registry Database.
The details of this registry plan include:
- Annual high-resolution computed tomography (HRCT) scans
- Annual cardiopulmonary exercise tests (CPET)
- Peripheral blood sampling for inclusion in a biobank
- Additionally, echocardiograms and pulmonary function tests will be conducted every six months.
The main questions it aims to answer are:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18 years old.
- •Diagnosed as ILD by a pulmonologist, rheumatologist or radiologist
- •Various casue of ILD, including Idiopathic pulmonary fibrosis (IPF), Connective tissue disease-associated interstitial lung disease (CTD-ILD), Unclassifed ILD, drug-induced ILD, lymphangioleiomyomatosis (LAM), and sarcoidosis-associated ILD.
排除标准
- •Under 18 years of age.
- •Failure to express informed consent in person.
结局指标
主要结局
All-cause mortality
时间窗: 10 years
All-cause mortality of the enrolled patients from enrollment to the death event
Annual rate of acute exacerbation
时间窗: through study completion, an average of 1 year
The event of visiting the emergency room or being hospitalized will be recorded
次要结局
- Annual rate of progressive pulmonary fibrosis(From date of enrolled until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months)
研究者
Pin-Kuei Fu, MD, PhD
Principal Investigator
Taichung Veterans General Hospital