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Idiopathic Pulmonary Fibrosis Job Exposures Study (IPFJES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211507
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : December 12, 2019
Sponsor:
Collaborators:
Wellcome Trust
University Hospital Southampton NHS Foundation Trust
Imperial College Healthcare NHS Trust
Heart of England NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
Papworth Hospital NHS Foundation Trust
Nottingham University Hospitals NHS Trust
University Hospital of South Manchester
Guy's and St Thomas' NHS Foundation Trust
North Bristol NHS Trust
The Leeds Teaching Hospitals NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Royal Devon and Exeter NHS Foundation Trust
Somerset NHS Foundation Trust
Royal Infirmary of Edinburgh
Morriston Hospital
Aberdeen Royal Infirmary
Worcestershire Acute Hospitals NHS Trust
University Hospital Birmingham NHS Foundation Trust
Portsmouth Hospitals NHS Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
Glasgow Royal Infirmary
Information provided by (Responsible Party):
Imperial College London

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A case-control study to investigate whether job exposures are an under-recognized cause of idiopathic pulmonary fibrosis (IPF) using an interview to collect information about previous jobs and a blood test to investigate genetic susceptibility.

Condition or disease Intervention/treatment
IPF Idiopathic Pulmonary Fibrosis Other: Computer-assisted telephone interview Genetic: Genetic analysis

Detailed Description:
Idiopathic pulmonary fibrosis (IPF) is a scarring lung disease. It damages the air sacs that allow oxygen to be transferred into the blood and transported to vital organs. These changes make people with IPF cough and feel short of breath. It not known what causes the damage. People who get IPF are usually older than 40; it's a very serious illness that cannot be cured and gets worse over time. Statistics show that IPF is becoming more common in the UK but it's not known why. It can be difficult for doctors to tell if someone has IPF or another disease called asbestosis.
Study Design
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Study Type : Observational
Actual Enrollment : 960 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Idiopathic Pulmonary Fibrosis Job Exposures Study
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : October 5, 2019
Actual Study Completion Date : October 5, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Case
Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019.
 Other: Computer-assisted telephone interview
Occupational history

Genetic: Genetic analysis
To include analysis of known susceptibility markers
Controls
Males with an incident hospital outpatient attendance between the 1st of February 2017 and the 5th of October 2019 who do not have a diagnosis of IPF. At each participating centre a control clinic is randomly selected from all control clinics that the research team is able to recruit from; this clinic is the source clinic for controls for the duration of the study.
 Other: Computer-assisted telephone interview
Occupational history

Genetic: Genetic analysis
To include analysis of known susceptibility markers


Outcome Measures
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Primary Outcome Measures :
  1. Association between asbestos exposure and IPF [ Time Frame: 2 years ]
    estimated using logistic regression for any vs no asbestos exposure and adjusting for age and smoking status


Secondary Outcome Measures :
  1. Dose-response relationship between asbestos exposure and IPF [ Time Frame: 2 years ]
    estimated using logistic regression for categories of cumulative exposure and adjusting for age and smoking status

  2. Gene-environment interaction (for MUC5B rs35705950 and asbestos exposure) odds ratio. [ Time Frame: 2 years ]
    MUC5B rs35705950 and asbestos exposure odds ratio.


Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospital based
Criteria

For cases

Inclusion Criteria:

  • New diagnosis of IPF between February 2017 and October 2019

Exclusion Criteria:

  • Unable to give informed consent
  • Ever worked outside of the UK

For controls

Inclusion Criteria:

  • New outpatient department attendee between February 2017 and October 2019

Exclusion Criteria:

  • Unable to give informed consent
  • Ever worked outside of the UK (does not include work outside the UK by members of the armed forces or merchant navy)
  • Diagnosis of IPF
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03211507


Locations
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United Kingdom
Imperial Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Wellcome Trust
University Hospital Southampton NHS Foundation Trust
Imperial College Healthcare NHS Trust
Heart of England NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
Papworth Hospital NHS Foundation Trust
Nottingham University Hospitals NHS Trust
University Hospital of South Manchester
Guy's and St Thomas' NHS Foundation Trust
North Bristol NHS Trust
The Leeds Teaching Hospitals NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Royal Devon and Exeter NHS Foundation Trust
Somerset NHS Foundation Trust
Royal Infirmary of Edinburgh
Morriston Hospital
Aberdeen Royal Infirmary
Worcestershire Acute Hospitals NHS Trust
University Hospital Birmingham NHS Foundation Trust
Portsmouth Hospitals NHS Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
Glasgow Royal Infirmary
Investigators
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Study Director: Carl Reynolds Imperial College London
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03211507    
Other Study ID Numbers: 16SM3627
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Imperial College London:
Idiopathic Pulmonary Fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases