Clinical trial NCT03670576: It's Not JUST Idiopathic Pulmonary Fibrosis Study
Official title: It's Not JUST Idiopathic Pulmonary Fibrosis Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
First posted: 2018-09-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from ILD and IPF clinics.

Brief summary: Study of progression of fibrosis in ILD

Detailed description: The overall aims of this study are

* 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

Eligibility criteria: Inclusion Criteria

* Male or female aged ≥ 18 years old
* 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:

* Participating in an interventional clinic trial
* 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)

Primary outcomes:
measure: Disease Progression
timeFrame: Within 12 months
measure: Overall Survival
timeFrame: 10 years
Secondary outcomes:
measure: Serum and Plasma Biomarkers
timeFrame: Baseline, 3 months, 12 months, 24 months
Other outcomes:
measure: DLco
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Quality of Life Questionnaires
timeFrame: Baseline, 3 months, 12 months, 24 months.
measure: Domicillary Spirometry
timeFrame: Daily for the first 3 months of study then at 2 week periods around time of planned follow up
Locations:
city: Burton on Trent
country: United Kingdom
facility: Queens Hospital Burton
state: Derbyshire
city: Mansfield
country: United Kingdom
facility: Kings Mill Hospital
state: Nottingham
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Trust
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital North Bristol
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: London
country: United Kingdom
facility: Kingston Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St Georges Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital
city: Stockton-on-Tees
country: United Kingdom
facility: University Hospital of North Tees
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
city: Wigan
country: United Kingdom
facility: Royal Albert and Edward Infirmary
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
Study officials:
References:
citation: 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.