PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT
NCT ID: NCT05609201
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
54 participants
OBSERVATIONAL
2023-06-01
2024-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
36 participants with a multidisciplinary team diagnosis of IPF or non-IPF fibrotic-ILD
HRCT Thorax
HRCT Thorax at 0, 6 and 12 months
Glycocheck Endothelial Glycocalyx Assessment
Measure of EG degradation using GlycoCheck Microvascular Health Score at 0, 6 and 12 months
Blood biomarkers
Endothelial glycocalyx degradation blood biomarkers and angiogenesis markers at 0, 6 and 12 months
Peripheral leucocyte telomere length
HT-STELA (High-throughput single telomere length assessment) at 0, 6 and 12 months
Pulmonary function testing
Pulmonary Function Tests (Spirometry and Gas Transfer) and 6-minute walk distance at 0, 6 and 12 months
Patient reported outcome measures
Electronic collection of patient reported outcome measures
Healthy Control
5 Age, sex and ethnicity matched controls
Glycocheck Endothelial Glycocalyx Assessment
Measure of EG degradation using GlycoCheck Microvascular Health Score at 0, 6 and 12 months
Blood biomarkers
Endothelial glycocalyx degradation blood biomarkers and angiogenesis markers at 0, 6 and 12 months
Peripheral leucocyte telomere length
HT-STELA (High-throughput single telomere length assessment) at 0, 6 and 12 months
Interventions
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HRCT Thorax
HRCT Thorax at 0, 6 and 12 months
Glycocheck Endothelial Glycocalyx Assessment
Measure of EG degradation using GlycoCheck Microvascular Health Score at 0, 6 and 12 months
Blood biomarkers
Endothelial glycocalyx degradation blood biomarkers and angiogenesis markers at 0, 6 and 12 months
Peripheral leucocyte telomere length
HT-STELA (High-throughput single telomere length assessment) at 0, 6 and 12 months
Pulmonary function testing
Pulmonary Function Tests (Spirometry and Gas Transfer) and 6-minute walk distance at 0, 6 and 12 months
Patient reported outcome measures
Electronic collection of patient reported outcome measures
Eligibility Criteria
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Inclusion Criteria
* Treatment naivety to anti-fibrotic therapy at entry to study
* Adult ≥18 years \<85
* Informed consent
Exclusion Criteria
* Significant other respiratory pathology including emphysema \>15% on CT (radiologist determined)
* Evidence of ILD exacerbation at the time of CT
18 Years
85 Years
ALL
Yes
Sponsors
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North Bristol NHS Trust
OTHER
Royal United Hospitals Bath NHS Foundation Trust
OTHER
Royal Devon and Exeter NHS Foundation Trust
OTHER
University of Exeter
OTHER
Responsible Party
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Principal Investigators
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Giles Dixon
Role: PRINCIPAL_INVESTIGATOR
University of Exeter
Locations
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University of Exeter Medical School
Exeter, , United Kingdom
Countries
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Other Identifiers
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2021-22-54
Identifier Type: -
Identifier Source: org_study_id
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