Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Nils Hoyer
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diagnosis of HP
研究概览
简要总结
Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data.
The database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016.
Biomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.
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
- •Diagnosis of HP at an MDT conference according to the current international guidelines
- •Age of 18 years or older
- •The patients must be capable of giving informed consent
排除标准
- •Unable to sign informed consent
结局指标
主要结局
Diagnosis of HP
时间窗: 0 days
MDT-Diagnosis of HP
Exposure to inciting antigen (patient reported)
时间窗: 0 days
Known exposure, as reported by the patient
Exposure to inciting antigen (measurable)
时间窗: 0 days
Measurable exposure, as tested by precipitins
Progression free survival
时间窗: 3 years
Survival without progression
Overall survival
时间窗: 3 years
Survival after diagnosis
次要结局
- Quality of life questionnaires(3 years)
- Pulmonary function test(3 years)
- Imaging(3 years)
研究者
Nils Hoyer
Principal Investigator
University Hospital, Gentofte, Copenhagen