It's Not JUST Idiopathic Pulmonary Fibrosis Study
INJUSTIS
1 other identifier
observational
250
1 country
24
Brief Summary
Study of progression of fibrosis in ILD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
November 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2022
CompletedJuly 2, 2021
July 1, 2021
4 years
August 6, 2018
July 1, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Disease Progression
Disease progression defined as \>10% relative decline in FVC (using either hospital spirometry or home hand held spirometry) or death within 12 months.
Within 12 months
Overall Survival
All patients will be tagged at the central NHS registry in order to provide mortality data. For this reason we will need to keep our datasets active for up to 10 years to allow a complete mortality analysis.
10 years
Secondary Outcomes (1)
Serum and Plasma Biomarkers
Baseline, 3 months, 12 months, 24 months
Other Outcomes (3)
DLco
Baseline, 3 months, 12 months, 24 months
Quality of Life Questionnaires
Baseline, 3 months, 12 months, 24 months.
Domicillary Spirometry
Daily for the first 3 months of study then at 2 week periods around time of planned follow up
Study Arms (2)
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.
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.
Interventions
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
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
Participants will be recruited from ILD and IPF clinics.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Queens Hospital Burton
Burton-on-Trent, Derbyshire, DE15 0RB, United Kingdom
Kings Mill Hospital
Mansfield, Nottingham, NG17 4JL, 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, BS10 5NB, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, CV2 2DX, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Medway Maritime Hospital
Gillingham, ME7 5NY, United Kingdom
Kingston Hospital NHS Foundation Trust
London, United Kingdom
St Georges Hospital
London, United Kingdom
North Manchester General Hospital
Manchester, M8 5RB, 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, NG5 1PB, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
South Tyneside District Hospital
South Shields, NE34 0PL, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE, United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, United Kingdom
Royal Albert and Edward Infirmary
Wigan, WN1 2NN, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Worcestershire Royal Hospital
Worcester, WR5 1DD, United Kingdom
Related Publications (2)
Khan F, Stewart I, Howard L, Barber CM, Borton R, Braybrooke R, Hearson G, Jones S, Maher T, Matthews L, Saini G, Thompson N, Wilson AM, Johnson SR, Jenkins G. Comprehensive characterisation of individuals with fibrotic interstitial lung disease: baseline insights from the INJUSTIS study. BMJ Open Respir Res. 2026 Jan 20;13(1):e003112. doi: 10.1136/bmjresp-2024-003112.
PMID: 41558800DERIVEDKhan 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.
PMID: 31258922DERIVED
Biospecimen
Blood (Serum, Plasma) Bronchoscopy Biopsy Samples (Optional)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
September 13, 2018
Study Start
November 11, 2018
Primary Completion
November 11, 2022
Study Completion
November 11, 2022
Last Updated
July 2, 2021
Record last verified: 2021-07