Idiopathic Pulmonary Fibrosis Job Exposures Study (IPFJES)

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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

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

MedlinePlus Genetics related topics: Idiopathic pulmonary fibrosis

MedlinePlus related topics: Asbestos Pulmonary Fibrosis

Genetic and Rare Diseases Information Center resources: Idiopathic Pulmonary Fibrosis

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

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 :

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
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

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