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Biomarkers of disease
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
  1. Fasihul Khan1,
  2. Iain Stewart2,
  3. Lucy Howard3,
  4. Tricia M McKeever2,
  5. Steve Jones4,
  6. Glenn Hearson5,
  7. Rebecca Braybrooke3,
  8. Colin Edwards6,
  9. Gisli Jenkins1 and
  10. Gauri Saini1
  1. 1Respiratory Medicine, University of Nottingham, Clinical Sciences Building, Nottingham City Hospital, Hucknall Road, Nottingham, UK
  2. 2Division of Epidemiology and Public Health, University of Nottingham, Clinical Sciences Building, Nottingham City Hospital, Hucknall Road, Nottingham, UK
  3. 3Respiratory Medicine, University of Nottingham, Clinical Sciences Building, Nottingham City Hospital, Hucknall Road, Nottingham, UK
  4. 4Action for Pulmonary Fibrosis, City Wharf, Davidson Road, Lichfield, Staffordshire, UK
  5. 5Respiratory Medicine, University Of Nottingham, Nottingham, UK
  6. 6patientMpower Ltd, The Digital Depot, Thomas Street, Dublin, Ireland
  1. Correspondence to Dr Gisli Jenkins; gisli.jenkins{at}nottingham.ac.uk

Abstract

Introduction The Its Not JUST Idiopathic pulmonary fibrosis Study (INJUSTIS) is a multicentre, prospective, observational cohort study. The aims of this study are to identify genetic, serum and other biomarkers that may identify specific molecular mechanisms, reflecting disease endotypes that are shared among patients with progressive pulmonary fibrosis regardless of aetiology. Furthermore, it is anticipated that these biomarkers will help predict fibrotic activity that may identify patterns of disease behaviour with greater accuracy than current clinical phenotyping.

Methods and analysis 200 participants with the multidisciplinary team confirmed fibrotic lung disease (50 each of rheumatoid-interstitial lung disease (ILD), asbestosis, chronic hypersensitivity pneumonitis and unclassifiable ILD) and 50 idiopathic pulmonary fibrosis participants, recruited as positive controls, will be followed up for 2 years. Participants will have blood samples, lung function tests, quality of life questionnaires and a subgroup will be offered bronchoscopy. Participants will also be given the option of undertaking blinded home handheld spirometry for the first 3 months of the study. The primary end point will be identification of a biomarker that predicts disease progression, defined as 10% relative change in forced vital capacity (FVC) or death at 12 months.

Ethics and dissemination The trial has received ethical approval from the National Research Ethics Committee Nottingham (18/EM/0139). All participants must provide written informed consent. The trial will be overseen by the INJUSTIS steering group that will include a patient representative, and an independent chairperson. The results from this study will be submitted for publication in peer-reviewed journals and disseminated at regional and national conferences.

Trial registration number NCT03670576.

  • interstitial fibrosis
  • asbestos induced lung disease
  • hypersensitivity pneumonitis

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjresp-2019-000439

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    Footnotes

    • Contributors GJ, GS, FK, LH, IS were involved in designing the study. FK wrote the manuscript and all authors reviewed it prior to submission. IS provided the sample size and statistical evaluation of the study design and is the trial statistician. CE was involved in writing the areas relevant to handheld spirometry and agrees with the content. SJ is the patient representative for the study.

    • Funding This study is being funded by the National Institute of Health Research (NIHR) through the Nottingham Biomedical Research Centre and a NIHR Professorship (RGJ). Trial Sponsor: University of Nottingham.

    • Competing interests CE is an employee and shareholder of patientMpower. RGJ reports grants from GlaxoSmithKline, UK Medical Research Council, Biogen, Galecto, MedImmune; as well as personal fees from Boehringer Ingelheim, Galapagos, GlaxoSmithKline, Heptares, MedImmune, Roche and Pulmatrix outside the submitted work; served as consultant for NuMedii and Pliant; a trustee for charities Action for Pulmonary Fibrosis and the British Thoracic Society.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; internally peer reviewed.