Optimising Screening for Early Disease Detection in Familial Pulmonary Fibrosis (FLORIS)
In this study the prognostic value of the current screening parameters for familial pulmonary fibrosis (FPF) will be investigated by looking at the screenings of 200 first-degree relatives of patients with FPF.
Also insight in the natural history of early FPF, and the necessary interval between screenings visits will be investigated.
研究概览
地位
详细说明
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Jan Grutters, Prof.
- 电话号码:+31883201453
- 邮箱:j.grutters@antoniusziekenhuis.nl
研究联系人备份
- 姓名:Martijn Maus, MD
- 电话号码:+31883201467
- 邮箱:m.maus@antoniusziekenhuis.nl
学习地点
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Nieuwegein、荷兰、3435CM
- 招聘中
- St Antonius hospital
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接触:
- Jan Grutters, Prof.
- 电话号码:+31883201453
- 邮箱:j.grutters@antoniusziekenhuis.nl
-
接触:
- Martijn Maus, MD
- 电话号码:+31883201467
- 邮箱:m.maus@antoniusziekenhuis.nl
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Asymptomatic first-degree relative of patients with familial pulmonary fibrosis (FPF)
Exclusion Criteria:
- A previous diagnosis of interstitial lung disease (ILD)
- Minors (aged <18 years)
- Pregnant
Note: woman who are pregnant at the start of the study or at the time of the HRCT are not allowed to participate. If a participant gets pregnant at a later stage during the study, she will not be excluded from the study. To be able to account for a potential effect of pregnancy during data analysis, female participants can be asked if they are pregnant at every visit.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Characteristics of participants
大体时间:Baseline
|
Difference in age, sex, body weight, smoking history and comorbidities between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Forced Vital Capacity (FVC)
大体时间:Baseline
|
Difference in forced vital capacity (FVC) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc)
大体时间:Baseline
|
Difference in haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Total lung capacity (TLC)
大体时间:Baseline
|
Difference in total lung capacity (TLC) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Biomarker levels
大体时间:Baseline
|
Difference in Krebs von den Lungen 6 (KL6), chemokine (C-C motif) ligand 18 (CCL18), surfactant protein-D (SP-D), matrix metalloproteinase 7 (MMP7) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Oxygen saturation in 6-minute walk test (6MWT)
大体时间:Baseline
|
Difference in oxygen saturation (rest in %), oxygen saturation (after 6MWT in %), oxygen saturation (nadir in %) and oxygen saturation (difference between rest and nadir in %) (all continuous variables) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Distance (meters) in 6-minute walk test (6MWT)
大体时间:Baseline
|
Difference in distance covered (in meters) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
MUC5B genotype
大体时间:Baseline
|
Difference in MUC5B genotype (all discrete variables) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Patient reported cough score
大体时间:Baseline
|
Difference in visual analogue scale (VAS) for cough (scores between 0-100, with 100 being the worst) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Patient reported dyspnea score
大体时间:Baseline
|
Difference in medical research council (MRC) (scores between 0-5, with 5 being the worst) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Clubbing
大体时间:Baseline
|
Difference in presence of digital clubbing between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
Crackles
大体时间:Baseline
|
Difference in inspiratory crackles during lung auscultation between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Forced Vital Capacity (FVC)
大体时间:2 years
|
Difference in forced vital capacity (FVC) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc)
大体时间:2 years
|
Difference in haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Total lung capacity (TLC)
大体时间:2 years
|
Difference in total lung capacity (TLC) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Biomarker levels
大体时间:2 years
|
Difference in KL6, CCL18, SP-D and MMP7 over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Genotype
大体时间:2 years
|
Difference in MUC5B genotype over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Oxygen saturation in 6-minute walk test (6MWT)
大体时间:2 years
|
Difference in oxygen saturation (rest in %), oxygen saturation (after 6MWT in %), oxygen saturation (nadir in %) and oxygen saturation (difference between rest and nadir in %) (all continuous variables) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Distance (meters) in 6-minute walk test (6MWT)
大体时间:2 years
|
Difference in distance covered (in meters) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Patient reported cough score
大体时间:2 years
|
Difference in visual analogue scale (VAS) for cough (scores between 0-100, with 100 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Patient reported dyspnea score
大体时间:2 years
|
Difference in medical research council (MRC) (scores between 0-5, with 5 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Digital clubbing
大体时间:2 years
|
Difference in presence of digital clubbing over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Crackles
大体时间:2 years
|
Difference in inspiratory crackles during lung auscultation over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Patient reported fatigue
大体时间:2 years
|
Difference in fatigue assessment scale (FAS) (scores range from 10-50, with 50 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
2 years
|
Patient reported health status
大体时间:2 years
|
Difference in EuroQol 5D-5L (EQ-5D-5L) (comprises of a score in five levels, level 1-5 with 5 being the worst, and a visual analoque scale ranging from 0-100 with 100 being the best) and the over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Relatedness
大体时间:Baseline
|
In case multiple members of the same family are included in the study
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Baseline
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Blood count
大体时间:2 years
|
Blood count (Consisting of; hemoglobin (mmol/l), erythrocytes (x10^12/l), mean corpuscular volume (fl), red cell distribution width (%), thrombocytes (x10^9/l), leukocytes (x10^9/l)) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between bloodcount in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
|
Creatinin
大体时间:2 years
|
creatinin (umol/l) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between creatinin in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
|
Liver function tests
大体时间:2 years
|
Liver function tests (consisting of: ASAT (U/l), ALAT (U/l), alkaline phosphatase (U/l), Gamma-glutamyl transpeptidase (U/l)) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between these liver function tests in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
|
Total bilirubin
大体时间:2 years
|
Total bilirubin (umol/l) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between total bilirubin in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
|
Additional blood based markers
大体时间:2 years
|
Additional blood based markers as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between these blood based markers in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
|
2 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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