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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UNKNOWN
250 participants
OBSERVATIONAL
2018-11-11
2022-11-11
Brief Summary
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Detailed Description
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* Identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology
* To prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including RA-UIP, Asbestosis, Chronic Hypersensitivity Pneumonitis and Unclassifiable fibrotic lung disease
* Investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression
* Prospectively evaluate longitudinal disease behaviour in patients with non IPF-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Case
A diagnosis of Fibrotic Lung disease classified in 4 categories, RA-UIP, Asbestosis, Chronic HP and Unclassifiable as agreed by an ILD MDT consensus panel.
Optional Bronchoscopy
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
Quality of Life Questionnaires
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
Blood Samples for Biomarkers
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Home Hand Held Spirometry
Patients will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)
Control
Positive control will be frequency matched to cases of ILD and will be people in secondary care who have an MDT diagnosis of Definite IPF.
Optional Bronchoscopy
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
Quality of Life Questionnaires
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
Blood Samples for Biomarkers
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Home Hand Held Spirometry
Patients will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)
Interventions
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Optional Bronchoscopy
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
Quality of Life Questionnaires
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
Blood Samples for Biomarkers
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Home Hand Held Spirometry
Patients will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)
Eligibility Criteria
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Inclusion Criteria
* Able and willing to give written informed consent
* Recently diagnosed \[defined as diagnostic CT scan or surgical lung biopsy (if applicable) \>1st May 2017\]
* An MDT diagnosis of fibrotic interstitial lung disease (reticulation, traction +/- honeycombing)
Sub Groups
* Rheumatoid arthritis (rheumatologist diagnosed with anti-CCP antibodies and/or Rheumatoid Factor positive)
* Asbestosis (appropriate occupational history and radiological evidence of asbestos exposure)
* Chronic HP in accordance with consensus criteria (appropriate exposure history, radiological features +/- avian and fungal precipitins)
* Unclassifiable fibrotic lung disease (fibrotic lung disease otherwise unclassifiable despite extensive clinical and radiological examination)
* IPF in accordance with consensus criteria (ATS/ERS/JRS/ALAT guidelines) as controls
Exclusion Criteria
* Asymptomatic Interstitial Lung Abnormalities (ILA) and normal lung function.
* Change in clinical phenotype from initial radiological diagnosis to screening
* Acute Hypersensitivity Pneumonitis.
* Participants who do not possess a smartphone or have a valid email address (necessary for the home FVC readings)
18 Years
ALL
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
University of Nottingham
OTHER
Responsible Party
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Locations
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Queens Hospital Burton
Burton-on-Trent, Derbyshire, United Kingdom
Kings Mill Hospital
Mansfield, Nottingham, United Kingdom
Royal United Hospitals Bath NHS Trust
Bath, , United Kingdom
University Hospitals Birmingham
Birmingham, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Southmead Hospital North Bristol
Bristol, , United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Kingston Hospital NHS Foundation Trust
London, , United Kingdom
St Georges Hospital
London, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Newcastle Upon Tyne NHS Foundation Trust
Newcastle, , United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
South Tyneside District Hospital
South Shields, , United Kingdom
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, , United Kingdom
Royal Albert and Edward Infirmary
Wigan, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dr Uttam Nanda
Role: primary
Dr Noeleen Foley
Role: primary
Dr Gareth Walters
Role: primary
Dr Thomas Bongers
Role: primary
Dr Huzaifa Adamali
Role: primary
Dr Srividya Narayan
Role: primary
Sarah Lines
Role: primary
Dr Lisa Vincent-Smith
Role: primary
Dr Siva Mahendran
Role: primary
Dr Raminder Aul
Role: primary
Dr Zoe Borrill
Role: primary
Dr Nazia Chaudhuri
Role: primary
Dr Sarah Wiscombe
Role: primary
Dr Laura McKay
Role: primary
Dr Steve Bianchi
Role: primary
Dr Liz Fuller
Role: primary
Dr Graham Miller
Role: primary
Dr James Davidson
Role: primary
Dr Abdul Ashish
Role: primary
Dr Ahmed Fahim
Role: primary
Prof Stephen O'Hickey
Role: primary
References
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Khan F, Stewart I, Howard L, McKeever TM, Jones S, Hearson G, Braybrooke R, Edwards C, Jenkins G, Saini G. The Its Not JUST Idiopathic pulmonary fibrosis Study (INJUSTIS): description of the protocol for a multicentre prospective observational cohort study identifying biomarkers of progressive fibrotic lung disease. BMJ Open Respir Res. 2019 Jun 4;6(1):e000439. doi: 10.1136/bmjresp-2019-000439. eCollection 2019.
Other Identifiers
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18014
Identifier Type: -
Identifier Source: org_study_id
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