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Idiopathic Pulmonary Fibrosis Job Exposures Study (IPFJES)
This study is currently recruiting participants.
Verified July 2017 by Imperial College London
Sponsor:
Imperial College London
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT03211507
First received: May 2, 2017
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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 | Intervention |
|---|---|
| IPF Idiopathic Pulmonary Fibrosis | Other: Computer-assisted telephone interview Genetic: Genetic analysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Control Time Perspective: Prospective |
| Official Title: | Idiopathic Pulmonary Fibrosis Job Exposures Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
idiopathic pulmonary fibrosis
MedlinePlus related topics:
Pulmonary Fibrosis
U.S. FDA Resources
Further study details as provided by Imperial College London:
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
| Estimated Enrollment: | 920 |
| Actual Study Start Date: | May 1, 2017 |
| Estimated Study Completion Date: | October 5, 2020 |
| Estimated Primary Completion Date: | October 5, 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211507
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT03211507 History of Changes |
| Other Study ID Numbers: |
16SM3627 |
| Study First Received: | May 2, 2017 |
| Last Updated: | July 5, 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 |
ClinicalTrials.gov processed this record on July 11, 2017