Silicosis-harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the SHIELD study primary outcome is to build up knowledge gap to accurately diagnose silicosis, as well as predict disease progress, assess response to treatment, hasten therapeutic discovery in 12 months.
研究概览
简要总结
An observational cohort study to derive biomarkers which are able to more accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery.
详细描述
Background: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone. AIMS: To establish the SHIELD COHORT and associated SHIELD BIOBANK to drive further discovery including assessing the efficacy of whole lung lavage for accelerated silicosis, uncovering disease biomarkers, and druggable targets.
PARTICIPANTS: 75 participants who are respirable crystalline silica exposed workers, (this includes n=30 with silicosis, n=15 with progressive massive fibrosis and n=30 with no pneumoconiosis). METHODS: Advanced microscopy, 'omic platforms and single cell RNA sequencing. OUTCOME: The SHIELD study builds on the knowledge gap to accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •All workers with a history of significant engineered stone exposure will be potentially eligible.
排除标准
- 未提供
结局指标
主要结局
the SHIELD study primary outcome is to build up knowledge gap to accurately diagnose silicosis, as well as predict disease progress, assess response to treatment, hasten therapeutic discovery in 12 months.
时间窗: 12 months
1. Establish the SHIELD cohort and associated lung fluid, tissue and blood biobank from well phenotyped RCS-exposed workers identified via the screening programs. 2. Utilise advanced microscopy, 'omic platforms and single cell RNA sequencing (scRNAseq) alongside conventional laboratory techniques, to identify and validate candidate lung and blood biomarkers associated with disease and disease progression at 12 months. 3. To evaluate associations between baseline characteristics, biomarkers and progression of disease in the full cohort.
次要结局
未报告次要终点