Interstitial Lung DiseaseINJUSTISNCT03670576
It's Not JUST Idiopathic Pulmonary Fibrosis Study
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by University of Nottingham at 24 sites in United Kingdom.
Trial summary
Study of progression of fibrosis in ILD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Optional Bronchoscopy, Quality of Life Questionnaires and Blood Samples for Biomarkers
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- 11 Nov 2018to 11 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from ILD and IPF clinics.
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites, 22 recruiting
- Recruiting
Royal United Hospitals Bath NHS Trust
Bath
Dr Noeleen Foley
- Recruiting
University Hospitals Birmingham
Birmingham
Dr Gareth Walters
- Recruiting
Blackpool Victoria Hospital
Blackpool
Dr Thomas Bongers
- Recruiting
Southmead Hospital North Bristol
Bristol, BS10 5NB
Dr Huzaifa Adamali
- Recruiting
Queens Hospital Burton
Burton-on-Trent, Derbyshire, DE15 0RB
Dr Uttam Nanda
- Active, not recruiting
University Hospitals Coventry and Warwickshire
Coventry, CV2 2DX
- Recruiting
Royal Derby Hospital
Derby, DE22 3NE
Dr Srividya Narayan
- Recruiting
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Sarah Lines
- Recruiting
Medway Maritime Hospital
Gillingham, ME7 5NY
Dr Lisa Vincent-Smith
- Recruiting
Kingston Hospital NHS Foundation Trust
London
Dr Siva Mahendran
- Recruiting
St Georges Hospital
London
Dr Raminder Aul
- Recruiting
North Manchester General Hospital
Manchester, M8 5RB
Dr Zoe Borrill
- Recruiting
Wythenshawe Hospital
Manchester
Dr Nazia Chaudhuri
- Active, not recruiting
Kings Mill Hospital
Mansfield, Nottingham, NG17 4JL
- Recruiting
Newcastle Upon Tyne NHS Foundation Trust
Newcastle
Dr Sarah Wiscombe
- Recruiting
Northumbria Healthcare NHS Foundation Trust
Newcastle
Dr Laura McKay
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Prof Gisli Jenkins, 0115 8231711, gisli.jenkins@nottingham.ac.uk
Lucy Howard, 0115 8231326, lucy.howard@nottingham.ac.uk
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Dr Steve Bianchi
- Recruiting
South Tyneside District Hospital
South Shields, NE34 0PL
Dr Liz Fuller
- Recruiting
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE
Dr Graham Miller
- Recruiting
Taunton and Somerset NHS Foundation Trust
Taunton
Dr James Davidson
- Recruiting
Royal Albert and Edward Infirmary
Wigan, WN1 2NN
Dr Abdul Ashish
- Recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
Dr Ahmed Fahim
- Recruiting
Worcestershire Royal Hospital
Worcester, WR5 1DD
Prof Stephen O'Hickey
About this study
Study of progression of fibrosis in ILD
Read the 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
- Being tested
- Optional Bronchoscopy, Quality of Life Questionnaires, Blood Samples for Biomarkers, Home Hand Held Spirometry
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optional BronchoscopyProcedure or surgery
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 QuestionnairesOther
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
Blood Samples for BiomarkersOther
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Home Hand Held SpirometryOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Optional Bronchoscopy; Other: Quality of Life Questionnaires; Other: Blood Samples for Biomarkers; Other: Home Hand Held Spirometry | |
| 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. Receives: Procedure: Optional Bronchoscopy; Other: Quality of Life Questionnaires; Other: Blood Samples for Biomarkers; Other: Home Hand Held Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 years
Secondary outcomes (1)
Serum and Plasma Biomarkers
SPD, MUC16, CA199, Nordic Neoepitopes
Measured: Baseline, 3 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start11 Nov 2018
- Primary completion11 Nov 2022 (estimated)
- Study completion11 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670576
- Sponsor's protocol ID
- 18014
- Acronym
- INJUSTIS
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2018
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41558800Khan 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.
PubMed 31258922
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- It's Not JUST Idiopathic Pulmonary Fibrosis Study
- ClinicalTrials.gov ID
- NCT03670576
- Acronym / sponsor ID
- INJUSTIS / 18014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 11 Nov 2022 (estimated)
- Study completion
- 11 Nov 2022 (estimated)
- First posted
- 13 Sep 2018 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: Optional Bronchoscopy, Other: Quality of Life Questionnaires, Other: Blood Samples for Biomarkers, Other: Home Hand Held SpirometryA 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 | – | Procedure: Optional Bronchoscopy, Other: Quality of Life Questionnaires, Other: Blood Samples for Biomarkers, Other: Home Hand Held SpirometryPositive control will be frequency matched to cases of ILD and will be people in secondary care who have an MDT diagnosis of Definite IPF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from ILD and IPF clinics.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Optional BronchoscopyPatients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline. | Procedure or surgery | Case, Control |
| Quality of Life QuestionnairesMRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months, | Other | Case, Control |
| Blood Samples for Biomarkersa 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months. | Other | Case, Control |
| Home Hand Held SpirometryPatients 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) | Other | Case, Control |
Primary outcome
Disease Progression
Time frame: Within 12 months
Disease progression defined as >10% relative decline in FVC (using either hospital spirometry or home hand held spirometry) or death within 12 months.
Overall Survival
Time frame: 10 years
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.
1 secondary outcome
Serum and Plasma Biomarkers
Time frame: Baseline, 3 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 41558800Khan 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.
- Derived from this study: PubMed 31258922Khan 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.
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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.
24 sites 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 and Idiopathic Pulmonary Fibrosis, run by University of Nottingham at 24 sites 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 10 inclusion and 5 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
Contact Prof Gisli Jenkins (0115 8231711, gisli.jenkins@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Progression (time frame: Within 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670576, which also lists 2 linked publications.
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 2 Jul 2021.