Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) 2
Research type
Research Study
Full title
The Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) 2 Study
IRAS ID
346371
Contact name
Nikhil Hirani
Contact email
Clinicaltrials.gov Identifier
07/S1102/20, REC number of previous identical project (minus amendments herein) that was REC approved pre-IRAS
Duration of Study in the UK
19 years, 11 months, 30 days
Research summary
Idiopathic pulmonary fibrosis (IPF) and other fibrotic and inflammatory interstitial lung disease (ILD) are forms of lung scarring and inflammation for which there are limited treatment options. IPF and other ILDs are rare diseases compared to other lung conditions. The management of patients with IPF and other ILD is particularly complex because there are a number of closely related fibrosing lung conditions that 'look' similar but have different underlying mechanisms and prognosis.
Since 2007 we have been collecting data and clinical samples from patients with ILD under ethically approved studies (ELFMEN, Edinburgh blood and lung biomarker study of pulmonary fibrosis and Scottish Interstitial Lung Disease [SCILD] Clinical Database Study). Due to new genetic, molecular and clinical data generated from our current ELFMEN cohort and other datasets together with novel technology, we now wish to create an ELFMEN-2 cohort of patients to validate previous findings, generate new hypotheses and share data and samples with authorised collaborators.STUDY DESIGN
Prospective longitudinal cohort study. This means we will be collecting clinical information including lung function (breathing tests) and CT scans and blood and lung samples from newly presenting patients with ILD to a chest clinic.
The clinical information, breathing tests and CT scans will all be part of routine clinical care and no extra research tests will be done. There will be additional blood samples at intervals taken that is part of research. A bronchoscopy test to obtain lung samples will be done as part of routine clinical care but additional research samples from the lungs will be taken as part of the procedure. A second bronchoscopy test will be for research only for patients that consent to this. The study will run for around 10 years and aim to collect around 1500 subjects. To increase the chances of discovering new treatment and monitoring options, the data and samples will be shared with other authorised researchers who have collected similar data and samples or have expertise in analysis.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
24/EM/0232
Date of REC Opinion
27 Nov 2024
REC opinion
Further Information Favourable Opinion