It's Not JUST Idiopathic Pulmonary Fibrosis Study (INJUSTIS)

July 1, 2021 updated by: University of Nottingham
Study of progression of fibrosis in ILD

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Bath, United Kingdom
        • Recruiting
        • Royal United Hospitals Bath NHS Trust
        • Contact:
          • Dr Noeleen Foley
      • Birmingham, United Kingdom
        • Recruiting
        • University Hospitals Birmingham
        • Contact:
          • Dr Gareth Walters
      • Blackpool, United Kingdom
        • Recruiting
        • Blackpool Victoria Hospital
        • Contact:
          • Dr Thomas Bongers
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • Southmead Hospital North Bristol
        • Contact:
          • Dr Huzaifa Adamali
      • Coventry, United Kingdom, CV2 2DX
        • Active, not recruiting
        • University Hospitals Coventry and Warwickshire
      • Derby, United Kingdom, DE22 3NE
        • Recruiting
        • Royal Derby Hospital
        • Contact:
          • Dr Srividya Narayan
      • Exeter, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon and Exeter Hospital
        • Contact:
          • Sarah Lines
      • Gillingham, United Kingdom, ME7 5NY
        • Recruiting
        • Medway Maritime Hospital
        • Contact:
          • Dr Lisa Vincent-Smith
      • London, United Kingdom
        • Recruiting
        • St Georges Hospital
        • Contact:
          • Dr Raminder Aul
      • London, United Kingdom
        • Recruiting
        • Kingston Hospital Nhs Foundation Trust
        • Contact:
          • Dr Siva Mahendran
      • Manchester, United Kingdom, M8 5RB
        • Recruiting
        • North Manchester General Hospital
        • Contact:
          • Dr Zoe Borrill
      • Manchester, United Kingdom
        • Recruiting
        • Wythenshawe Hospital
        • Contact:
          • Dr Nazia Chaudhuri
      • Newcastle, United Kingdom
        • Recruiting
        • Northumbria Healthcare NHS Foundation Trust
        • Contact:
          • Dr Laura McKay
      • Newcastle, United Kingdom
        • Recruiting
        • Newcastle upon Tyne NHS Foundation Trust
        • Contact:
          • Dr Sarah Wiscombe
      • Nottingham, United Kingdom, NG5 1PB
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Dr Steve Bianchi
      • South Shields, United Kingdom, NE34 0PL
        • Recruiting
        • South Tyneside District Hospital
        • Contact:
          • Dr Liz Fuller
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • Recruiting
        • University Hospital of North Tees
        • Contact:
          • Dr Graham Miller
      • Taunton, United Kingdom
        • Recruiting
        • Taunton and Somerset NHS Foundation Trust
        • Contact:
          • Dr James Davidson
      • Wigan, United Kingdom, WN1 2NN
        • Recruiting
        • Royal Albert and Edward Infirmary
        • Contact:
          • Dr Abdul Ashish
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • New Cross Hospital
        • Contact:
          • Dr Ahmed Fahim
      • Worcester, United Kingdom, WR5 1DD
        • Recruiting
        • Worcestershire Royal Hospital
        • Contact:
          • Prof Stephen O'Hickey
    • Derbyshire
      • Burton on Trent, Derbyshire, United Kingdom, DE15 0RB
        • Recruiting
        • Queens Hospital Burton
        • Contact:
          • Dr Uttam Nanda
    • Nottingham
      • Mansfield, Nottingham, United Kingdom, NG17 4JL
        • Active, not recruiting
        • Kings Mill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be recruited from ILD and IPF clinics.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Optional Bronchoscopy
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
Other: Quality of Life Questionnaires
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
Other: Blood Samples for Biomarkers
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Other: 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.
Procedure: Optional Bronchoscopy
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
Other: Quality of Life Questionnaires
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
Other: Blood Samples for Biomarkers
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum and Plasma Biomarkers
Time Frame: Baseline, 3 months, 12 months, 24 months
SPD, MUC16, CA199, Nordic Neoepitopes
Baseline, 3 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLco
Time Frame: Baseline, 3 months, 12 months, 24 months
Diffusing Capacity of the Lung for Carbon Monoxide
Baseline, 3 months, 12 months, 24 months
Quality of Life Questionnaires
Time Frame: Baseline, 3 months, 12 months, 24 months.
Assessment of how the patients well-being may be affected over time by their interstitial lung disease
Baseline, 3 months, 12 months, 24 months.
Domicillary Spirometry
Time Frame: Daily for the first 3 months of study then at 2 week periods around time of planned follow up
Change in home handheld spirometry values from baseline to 12 weeks
Daily for the first 3 months of study then at 2 week periods around time of planned follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2018

Primary Completion (Anticipated)

November 11, 2022

Study Completion (Anticipated)

November 11, 2022

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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