Idiopathic Pulmonary Fibrosis Job Exposures Study (IPFJES)

• ClinicalTrials.gov Identifier: NCT03211507
• Recruitment Status: Completed
• First Posted: July 7, 2017
• Last Update Posted: December 12, 2019
• 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
• 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

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

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

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

• Current Responsible Party: Imperial College London
• Original Responsible Party: Same as current
• Current Study Sponsor: Imperial College London
• Original Study Sponsor: Same as current

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