Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05609201
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2022-11-01
Brief Title:
PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT
Sponsor:
University of Exeter
Organization:
University of Exeter
Study Overview
Official Title:
PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDICT-ILD
Brief Summary:
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 interintra-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
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 interintra-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None