Short summary

By establishing a research database of patients with interstitial lung diseases (ILD), this project aim to evaluate potential clinical tools for assessment of disease activity in ILD.

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Rationale

Interstitial lung diseases (ILD) represent a heterogeneous disease category with different clinical, radiological, and histological characteristics of which many have fatal prognosis with a median survival of 3-5 years. Despite an increased focus on e.g. biomarkers, we lack accurate diagnostic instruments to predict the individual ILD patient's risk of disease exacerbation. Thus, there is a clear need for research into identification and validation of more accurate and objective clinically useful tools including biomarkers to estimate disease status, treatment response, and phenotypic characteristics. Such information will help the clinician to identify ILD patients at high risk of disease progression with poor prognosis in order to tailor treatment, prevention and rehabilitation.

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Description of the cohort

In the Region of Southern Denmark, management of ILDs is accomplished at the Interstitial Outpatient Clinic affiliated the Department of Respiratory Medicine at Odense University Hospital (OUH), which serves as a tertiary referral centre receiving unselected patients from the local area of OUH as well as within the Region.

In this tertiary ILD single centre setting a prospective observational study is performed on basis of a dynamic cohort of patients referred under suspicion of ILD.

Data and biological material

Included patients undergo a conventional examination programme (e.g. clinical examination, thorough medical history with focus on potential exposures associated with ILD, blood tests, bodypletysmography, 6MWD, radiological imaging, echocardiography) due to their the first clinical attendance, and at follow up after 6 and 12 months. This programme is supplemented with possible clinical tools for assessment of ILD disease activity:

• Lung UltraSound (LUS)
• Lung Clearance Index (LCI)
• Exhaled metabolites of breath (eVOCs (exhaled volatile organic compounds))
• Blood tests for later on analysis of biomarkers in blood (BiB) in an OPEN biobank

LCI, eVOC, and BiBs will be analysed to evaluate their usefulness, and, if so, to phenotype the different ILD subtypes. LUS and HRCT (used as golden standard) findings will be compared to assess LUS as a diagnostic and monitoring tool for inflammation and fibrosis in ILD. Variations in LUS, LCI, eVOC, and BiB measurements between first clinical attendance and at follow-up(s) will be analysed to determine their appropriateness in the assessment of disease status.

Collaborating researchers and departments

Institute of Molecular Medicine (IMM), University of Southern Denmark

• Professor Uffe Holm Skov, MD, DMSc, PhD

Nordic Bioscience A/S, Copenhagen and University of Southern Denmark

• CEO and Assigned Professor Morten Karsdal, MSc, PhD

Department of Emergency Medicine (FAM), Odense University Hospital

• Professor AnnMarie Lassen, MD, DMSci, PhD

Research Unit of Respiratory Medicine, Department of Respiratory Medicine, Odense University Hospital

• Christian Borbjerg Laursen, MD, PhD
• Anders Christiansen, MD, PhD-fellow

Research Unit of General Practice, Institute of Public Health, University of Southern Denamrk

• Biostatistician René dePont Christensen, PhD

Department of Mathematics and Computer Science (IMADA), University of Southern Denmark

• Lecturer Jan Baumbach, MSc, PhD

Research Unit of Clinical Pharmacology, Intitute of Public Health, University of Southern Denmark

• Professor Jesper Hallas, MD, DMSc

West Danish Centre for Interstitial Lung Diseases, Department of Respiratory Medicine, Aarhus University Hospital

• Clinical Associate Professor Elisabeth Bendstrup, MD, PhD

Publications associated with the project

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