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BPF Genetics of ILD Study (BPF GILD)

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ClinicalTrials.gov Identifier: NCT03747627
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
University of Leicester
University of Glasgow
Newcastle University
British Lung Foundation
British Pigeon Fanciers Medical Research
Information provided by (Responsible Party):
Mark Spears, NHS Forth Valley

Brief Summary:
The investigators aim to examine the genetic determinants of interstitial lung disease in a cohort of subjects with regular exposure to pigeons, a known cause of one form of interstitial lung disease known as hypersensitivity pneumonitis. The investigators hope the investigator's work will provide insights of use to clinicians and patients with hypersensitivity pneumonitis and other interstitial lung diseases.

Condition or disease Intervention/treatment
Lung; Disease, Interstitial, With Fibrosis Alveolitis, Extrinsic Allergic Bird Fancier's Lung Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial Idiopathic Pulmonary Fibrosis Diagnostic Test: Genetic profiling

Detailed Description:

The investigators aim to recruit participants with regular racing pigeon exposure at national (UK) and regional pigeon fancier meetings.

Consenting subjects will complete questionnaires, provide blood samples for genetic analysis and undertake lung function measurements.

Subjects will be observed, and encouraged to report referral to specialist respiratory services, and following this information will be sought on diagnosis (including supporting evidence). Where interstitial lung disease is detected this will be linked to subsequent unbiased analysis to detect potential predisposing genetic associations.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: British Pigeon Fanciers Genetics of Interstitial Lung Disease Study
Actual Study Start Date : January 19, 2019
Estimated Primary Completion Date : January 22, 2024
Estimated Study Completion Date : January 1, 2028



Intervention Details:
  • Diagnostic Test: Genetic profiling
    All participating subjects will undergo detailed genetic analysis, with the aim of detecting novel genetic drivers for the development of interstitial lung disease in the context of known sensitising agent (pigeon antigen)


Primary Outcome Measures :
  1. Relationship of specific genetic markers to development of interstitial lung disease [ Time Frame: 5 years ]
    Participants will be screened for MUC5B genetic profile to allow examination of MUC5B genetic profile relationship with risk of developing interstitial lung disease in this group


Biospecimen Retention:   Samples With DNA
Blood samples will be prepared for DNA analysis


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants in the sport of Pigeon racing
Criteria

Inclusion Criteria:

  • regular exposure to racing pigeons

Exclusion Criteria:

  • Unwilling to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747627


Contacts
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Contact: Mark Spears, PhD, FRCP +44 1324566853 markspears@nhs.net
Contact: Allyson Bailley, PhD +44 1786463031 allyson.bailey@nhs.net

Locations
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United Kingdom
Royal Pigeon Racing Association Meeting Recruiting
Blackpool, United Kingdom, FY1 1HL
Contact: Mark Spears, PhD FRCP         
Sponsors and Collaborators
NHS Forth Valley
University of Leicester
University of Glasgow
Newcastle University
British Lung Foundation
British Pigeon Fanciers Medical Research
Investigators
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Principal Investigator: Mark Spears, PhD, FRCP NHS Forth Valley

Additional Information:

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Responsible Party: Mark Spears, Dr Mark Spears, Consultant in Respiratory Medicine, NHS Forth Valley
ClinicalTrials.gov Identifier: NCT03747627     History of Changes
Other Study ID Numbers: MS001
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will be considered, dependent on potential for increased power

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

Keywords provided by Mark Spears, NHS Forth Valley:
Interstitial Lung Disease (ILD)
Hypersensitivity Pneumonitis
Idiopathic Pulmonary Fibrosis (IPF)
Extrinsic Allergic Alveolitis (EAA)
Bird Fancier's Lung
Genetics

Additional relevant MeSH terms:
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Fibrosis
Pneumonia
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Bird Fancier's Lung
Alveolitis, Extrinsic Allergic
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Occupational Diseases