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Idiopathic Pulmonary Fibrosis Job Exposures Study (IPFJES)

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ClinicalTrials.gov Identifier: NCT03211507
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London

Study Description
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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

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 920 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Idiopathic Pulmonary Fibrosis Job Exposures Study
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : October 5, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Case
Males with an incident diagnosis of IPF
 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 who do not have IPF
 Other: Computer-assisted telephone interview
Occupational history
Genetic: Genetic analysis
To include analysis of known susceptibility markers


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
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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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


Contacts
Contact: Carl Reynolds +44 (0)207 352 8121 ext 3364 carl.reynolds@imperial.ac.uk
Contact: Paul Cullinan p.cullinan@imperial.ac.uk

Locations
United Kingdom
Imperial Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Carl Reynolds, MBBS         
Sponsors and Collaborators
Imperial College London
Wellcome Trust
Investigators
Study Director: Carl Reynolds Imperial College London
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Full study documentation  This link exits the ClinicalTrials.gov site

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

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

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