A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF
研究概览
简要总结
The goal of this observational study is to learn about risk of progressive pulmonary fibrosis (PPF). The main questions it aims to answer are:
- Risk factors of PPF
- Prevalence of PPF
- Mortality of PPF
Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis will enroll in this study.
- All participants will have baseline investigations at the first visit having provided informed consent.
- At the first visit, baseline characteristics will be collected including demographics, medical history, smoking history, complications and medication use. 50 mL of blood will be obtained. High resolution computed tomography (HRCT), full lung function tests and a 6 min walk test will be performed.
- Further visits at 6 months and 12 months will include further 50 mL blood sampling. HRCT, full lung function tests and a 6 min walk test will be repeated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Agree and sign the informed consent form
- •Interstitial lung disease patients with imaging features of pulmonary fibrosis
排除标准
- •Patients with idiopathic pulmonary fibrosis (IPF)
- •Pregnant or lactating women
- •mental illness or cognitive impairment
- •participating in other clinical studies
- •Unable to sign informed consent form
结局指标
主要结局
Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF
时间窗: Up to 12 months
Establish the correlation between Artery blood gas and progression to PPF
时间窗: Up to 12 months
Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)
Establish the correlation between Biomarkers and progression to PPF
时间窗: Up to 12 months
Biomarkers:CCL18(pg/mL),KL-6(pg/mL),CA125(pg/mL),MMP-7(pg/mL),SP-D(pg/mL) and IL-6(pg/mL)
Establish the correlation between Age (years) and progression to PPF
时间窗: Up to 12 months
Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF
时间窗: Up to 12 months
Establish the correlation between 6 min walk test distance (meters) and progression to PPF
时间窗: Up to 12 months
Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF
时间窗: Up to 12 months
Establish the correlation between Pulmonary function and progression to PPF
时间窗: Up to 12 months
Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)
次要结局
- Prevalence of PPF(Up to 36 months)
研究者
Zhi Guo
Principal Investigator
Qianfoshan Hospital