PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Prediction of disease progression using multi-modal assessment
研究概览
简要总结
The interstitial lung diseases (ILD) are a heterogenous group of conditions with varying degrees of inflammation and scarring (fibrosis) of the lungs. ILD progression is unpredictable, making prognostication challenging. A proportion of patients will develop inexorably progressive disease termed progressive fibrosing ILD (PF-ILD).
Forced vital capacity (FVC), a lung function variable, is routinely used to monitor disease progression. However FVC can be a poor disease marker as it can be influenced by patient effort and can be difficult to perform. High resolution computed tomography (HRCT) is a necessary investigation for suspected fibrotic-ILD, making it a promising tool for research.
A quantitative-CT (qCT) approach uses computer software to analyse HRCT scans and has advantage over visual radiologist assessments which are limited by inter/intra-observer variance. The investigators will undertake a feasibility study to determine whether baseline and longitudinal qCT can predict and quantify disease progression in fibrotic-ILD.
The endothelial glycocalyx (EG) is a mesh-like layer that lines the small blood vessels. Injury to this layer has been implicated in non-thoracic fibrotic diseases. Telomeres are repetitive genetic sequences which cap chromosomes preventing their damage during cell replication. Prematurely shortened leucocyte telomere lengths (LTL) have been demonstrated in a wide range of ILDs. We will evaluate role of measuring EG health and LTL in disease prognostication.
Adult participants with fibrotic-ILD from 3 centres in England will be recruited alongside healthy controls. Case (disease) participants will undergo investigations at 0, 6 and 12 months from recruitment including:
- HRCT with quantitative analysis (qCT)
- Lung function testing
- EG and LTL measurement
- Health related quality of life assessments
The primary outcome will assess the correlation of disease progression status measured by standard of care (FVC) with baseline qCT and EG assessment. Healthy controls will only undergo EG assessment at all time points. Feasibility outcomes will be assessed including recruitment, consent and attrition rates.
The results will inform a subsequent multi-centre study to assess the clinical benefit of disease monitoring with the measures assessed in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Multidisciplinary team diagnosis of IPF or non-IPF fibrotic-ILD
- •Treatment naivety to anti-fibrotic therapy at entry to study
- •Adult ≥18 years <85
- •Informed consent
排除标准
- •Forced expiratory volume in 1s/FVC <0.7,
- •Significant other respiratory pathology including emphysema >15% on CT (radiologist determined)
- •Evidence of ILD exacerbation at the time of CT
结局指标
主要结局
Prediction of disease progression using multi-modal assessment
时间窗: 12 months
Correlation of disease progression status (progressor vs non-progressor) with baseline markers including: 1. Endothelial glycocalyx health via GlycoCheckTM and blood biomarkers 2. qCT metrics 3. Peripheral leucocyte telomere length measured via HT-STELA
Endothelial glycocalyx
时间窗: 12 months
III. Comparison of endothelial glycocalyx health between healthy controls and participants with fibrotic interstitial lung disease
Feasibility of using qCT for disease prognostication and monitoring
时间窗: 12 months
Recruitment, consent and attrition rates and dropout reasons
次要结局
- Exploratory mechanisms(12 months)
- Longitudinal disease progression(12 months)
- Prediction of disease progression(12 months)