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The Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) Study (ELFMEN)

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ClinicalTrials.gov Identifier: NCT04016181
Recruitment Status : Enrolling by invitation
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nikhil Hirani, University of Edinburgh

Brief Summary:
To prospectively study novel blood and lung biomarkers of disease activity in patients with IPF and other interstitial lung disease with the aims of prognostic modelling and disease clustering

Condition or disease
Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Asbestosis

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: The Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) Study
Actual Study Start Date : June 14, 2007
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : January 1, 2023





Primary Outcome Measures :
  1. Time to death (all cause) [ Time Frame: 15 years ]
    Biomarkers that are associated with increased all-cause mortality


Secondary Outcome Measures :
  1. Rate of decline in vital capacity [ Time Frame: 15 years ]
    Biomarkers that are associated with increased rate of decline in vital capacity (VC)

  2. Time to death (lung-related) [ Time Frame: 15 years ]
    Biomarkers that are associated with increased lung-related mortality

  3. Rate of decline in TLCO [ Time Frame: 15 years ]
    Biomarkers that predict rate of change in gas transfer (TLCO)


Other Outcome Measures:
  1. Identification of novel disease clusters [ Time Frame: 15 years ]
    Identification of discrete disease entities based on clinical, imaging and molecular data

  2. Time to oxygen prescription [ Time Frame: 15 years ]
    Biomarkers that are associated with reduced time to prescription of long term oxygen


Biospecimen Retention:   Samples With DNA
Serum EDTA blood Bronchoalveolar lavage (fluid and cells) Lung biopsy (fresh and formalin fixed)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with all entities of interstitial lung disease
Criteria

Inclusion Criteria:

  • patients with interstitial lung disease attending the Edinburgh Lung Fibrosis service

Exclusion Criteria:

  • candidates not a suitable for enrolment or unlikely to comply with the requirements of this study, in the opinion of the investigator, will be excluded.

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Responsible Party: Nikhil Hirani, Reader and Honorary Consultant in Respiratory Medicine, University of Edinburgh
ClinicalTrials.gov Identifier: NCT04016181     History of Changes
Other Study ID Numbers: 07/S1102/20
2007/R/RES/02 ( Other Identifier: University of Edinburgh and NHS Lothian )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: sharing of individual participant data will be determined on a case-by-case basis contingent of data security governance

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Asbestosis
Pathologic Processes
Respiratory Tract Diseases
Pneumoconiosis
Lung Injury
Occupational Diseases