NCT02574143Unknown不适用
The PROspective German NOn-CF bronchiectaSIS Patient Registry
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 750
- 试验地点
- 19
- 主要终点
- Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany
研究概览
简要总结
The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany.
详细描述
- To study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany
- To establish feasible investigational strategies in order to establish the etiology of NCFB
- To perform observational research into bronchiectasis, particularly in areas where single center datasets are underpowered, such as in rare etiologies or determining markers of prognosis
- To promote collaborative clinical, basic and translational research in NCFB between German (and European) centers
- To provide a registry of well phenotyped patients with NCFB in clinical centers potentially eligible for enrolment into clinical trials
- To track access to healthcare and cost of caring for patients with NCFB over time
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •A clinical history consistent with bronchiectasis
- •(High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes
排除标准
- •Bronchiectasis due to known cystic fibrosis (CF)
- •Age <18 years
- •Interstitial lung disease
- •Prior lung or heart-lung transplantation
结局指标
主要结局
Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany
时间窗: three years
To establish a national, representative, prospective, observational and longitudinal NCFB database and collaborative research network with a database including a minimum of 750 patients from a minimum of 25 centers from all levels of healthcare across Germany after a period of 3 years.
次要结局
- Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care(three years)
研究者
研究点 (19)
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