Interstitial Lung DiseasePREDICT-ILDNCT05609201
PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT
An observational study of Interstitial Lung Disease, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- HRCT Thorax, Glycocheck Endothelial Glycocalyx Assessment and Blood biomarkers
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants under the clinical care of the interstitial lung disease teams at the following hospitals: * Royal University Hospitals Bath NHS Foundation Trust, UK * Royal Devon University Healthcare, UK * North Bristol NHS Foundation Trust
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Interstitial Lung Disease
- Being tested
- HRCT Thorax, Glycocheck Endothelial Glycocalyx Assessment, Blood biomarkers, Peripheral leucocyte telomere length, Pulmonary function testing
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRCT ThoraxDiagnostic test
HRCT Thorax at 0, 6 and 12 months
Glycocheck Endothelial Glycocalyx AssessmentDevice
Measure of EG degradation using GlycoCheck Microvascular Health Score at 0, 6 and 12 months
Blood biomarkersDiagnostic test
Endothelial glycocalyx degradation blood biomarkers and angiogenesis markers at 0, 6 and 12 months
Peripheral leucocyte telomere lengthDiagnostic test
HT-STELA (High-throughput single telomere length assessment) at 0, 6 and 12 months
Pulmonary function testingDiagnostic test
Pulmonary Function Tests (Spirometry and Gas Transfer) and 6-minute walk distance at 0, 6 and 12 months
Patient reported outcome measuresDiagnostic test
Electronic collection of patient reported outcome measures
| Study group | Role | What they receive |
|---|---|---|
| Cases | 36 participants with a multidisciplinary team diagnosis of IPF or non-IPF fibrotic-ILD Receives: Diagnostic Test: HRCT Thorax; Device: Glycocheck Endothelial Glycocalyx Assessment; Diagnostic Test: Blood biomarkers; Diagnostic Test: Peripheral leucocyte telomere length; Diagnostic Test: Pulmonary function testing; Diagnostic Test: Patient reported outcome measures | |
| Healthy Control | 5 Age, sex and ethnicity matched controls Receives: Device: Glycocheck Endothelial Glycocalyx Assessment; Diagnostic Test: Blood biomarkers; Diagnostic Test: Peripheral leucocyte telomere length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of disease progression using multi-modal assessment
Correlation of disease progression status (progressor vs non-progressor) with baseline markers including:
- Endothelial glycocalyx health via GlycoCheckTM and blood biomarkers
- qCT metrics
- Peripheral leucocyte telomere length measured via HT-STELA
Measured: 12 months
Feasibility of using qCT for disease prognostication and monitoring
Recruitment, consent and attrition rates and dropout reasons
Measured: 12 months
Endothelial glycocalyx
III. Comparison of endothelial glycocalyx health between healthy controls and participants with fibrotic interstitial lung disease
Measured: 12 months
Secondary outcomes (3)
Longitudinal disease progression
Correlation of longitudinal change of pulmonary function testing:
- Endothelial glycocalyx health via GlycoCheckTM and blood biomarkers
- qCT metrics
- Peripheral leucocyte telomere length measured via HT-STELA
Measured: 12 months
Exploratory mechanisms
Exploratory analysis of the data to infer causal mechanisms of disease progression
Measured: 12 months
Prediction of disease progression
III. Exploratory analysis of the ability of 6 month qCT and PFT change to predict progression at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jun 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- North Bristol NHS Trust, Royal United Hospitals Bath NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Giles Dixon, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609201
- Sponsor's protocol ID
- 2021-22-54
- Acronym
- PREDICT-ILD
- Status last verified
- May 2024
- First submitted
- 1 Nov 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available on an anonymised basis via Open Research Exeter data depository (https://ore.exeter.ac.uk/repository).
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT
- ClinicalTrials.gov ID
- NCT05609201
- Acronym / sponsor ID
- PREDICT-ILD / 2021-22-54
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- North Bristol NHS Trust, Royal United Hospitals Bath NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: HRCT Thorax, Device: Glycocheck Endothelial Glycocalyx Assessment, Diagnostic Test: Blood biomarkers, Diagnostic Test: Peripheral leucocyte telomere length, Diagnostic Test: Pulmonary function testing, Diagnostic Test: Patient reported outcome measures36 participants with a multidisciplinary team diagnosis of IPF or non-IPF fibrotic-ILD |
| Healthy Control | – | Device: Glycocheck Endothelial Glycocalyx Assessment, Diagnostic Test: Blood biomarkers, Diagnostic Test: Peripheral leucocyte telomere length5 Age, sex and ethnicity matched controls |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants under the clinical care of the interstitial lung disease teams at the following hospitals: * Royal University Hospitals Bath NHS Foundation Trust, UK * Royal Devon University Healthcare, UK * North Bristol NHS Foundation Trust
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRCT ThoraxHRCT Thorax at 0, 6 and 12 months | Diagnostic test | Cases |
| Glycocheck Endothelial Glycocalyx AssessmentMeasure of EG degradation using GlycoCheck Microvascular Health Score at 0, 6 and 12 months | Device | Cases, Healthy Control |
| Blood biomarkersEndothelial glycocalyx degradation blood biomarkers and angiogenesis markers at 0, 6 and 12 months | Diagnostic test | Cases, Healthy Control |
| Peripheral leucocyte telomere lengthHT-STELA (High-throughput single telomere length assessment) at 0, 6 and 12 months | Diagnostic test | Cases, Healthy Control |
| Pulmonary function testingPulmonary Function Tests (Spirometry and Gas Transfer) and 6-minute walk distance at 0, 6 and 12 months | Diagnostic test | Cases |
| Patient reported outcome measuresElectronic collection of patient reported outcome measures | Diagnostic test | Cases |
Primary outcome
Prediction of disease progression using multi-modal assessment
Time frame: 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
Feasibility of using qCT for disease prognostication and monitoring
Time frame: 12 months
Recruitment, consent and attrition rates and dropout reasons
Endothelial glycocalyx
Time frame: 12 months
III. Comparison of endothelial glycocalyx health between healthy controls and participants with fibrotic interstitial lung disease
3 secondary outcomes
Longitudinal disease progression
Time frame: 12 months
Exploratory mechanisms
Time frame: 12 months
Prediction of disease progression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be available on an anonymised basis via Open Research Exeter data depository (https://ore.exeter.ac.uk/repository).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles Dixon principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of disease progression using multi-modal assessment (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.