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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

Tracking Information
First Submitted Date May 2, 2017
First Posted Date July 7, 2017
Last Update Posted Date December 12, 2019
Actual Study Start Date May 1, 2017
Actual Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 5, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Idiopathic Pulmonary Fibrosis Job Exposures Study
Official Title Idiopathic Pulmonary Fibrosis Job Exposures Study
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood
Sampling Method Probability Sample
Study Population Hospital based
Condition
  • IPF
  • Idiopathic Pulmonary Fibrosis
Intervention
  • Other: Computer-assisted telephone interview
    Occupational history
  • Genetic: Genetic analysis
    To include analysis of known susceptibility markers
Study Groups/Cohorts
  • Case
    Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019.
    Interventions:
    • Other: Computer-assisted telephone interview
    • Genetic: Genetic analysis
  • 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.
    Interventions:
    • Other: Computer-assisted telephone interview
    • Genetic: Genetic analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 10, 2019)
960
Original Estimated Enrollment
 (submitted: July 5, 2017)
920
Actual Study Completion Date October 5, 2019
Actual Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03211507
Other Study ID Numbers 16SM3627
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor Imperial College London
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
Investigators
Study Director: Carl Reynolds Imperial College London
PRS Account Imperial College London
Verification Date December 2019