IPFIPFJESNCT03211507
Idiopathic Pulmonary Fibrosis Job Exposures Study
An observational study of IPF and Idiopathic Pulmonary Fibrosis, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- IPF, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Computer-assisted telephone interview and Genetic analysis
- How many people
- 960 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 5 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital based
Who may be able to join
- New diagnosis of IPF between February 2017 and October 2019
- New outpatient department attendee between February 2017 and October 2019
Who cannot join
- Unable to give informed consent
- Ever worked outside of the UK
- For controls
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- IPF, Idiopathic Pulmonary Fibrosis
- Being tested
- Computer-assisted telephone interview, Genetic analysis
- Keywords
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted telephone interviewOther
Occupational history
Genetic analysisGenetic
To include analysis of known susceptibility markers
| Study group | Role | What they receive |
|---|---|---|
| Case | Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019. Receives: 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. Receives: Other: Computer-assisted telephone interview; Genetic: Genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between asbestos exposure and IPF
estimated using logistic regression for any vs no asbestos exposure and adjusting for age and smoking status
Measured: 2 years
Secondary outcomes (2)
Dose-response relationship between asbestos exposure and IPF
estimated using logistic regression for categories of cumulative exposure and adjusting for age and smoking status
Measured: 2 years
Gene-environment interaction (for MUC5B rs35705950 and asbestos exposure) odds ratio.
MUC5B rs35705950 and asbestos exposure odds ratio.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 May 2017
- Primary completion5 Oct 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IPFStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Carl Reynolds, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211507
- Sponsor's protocol ID
- 16SM3627
- Acronym
- IPFJES
- Status last verified
- Dec 2019
- First submitted
- 2 May 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reynolds CJ, Sisodia R, Barber C, Moffatt M, Minelli C, De Matteis S, Cherrie JW, Newman Taylor A, Cullinan P. What role for asbestos in idiopathic pulmonary fibrosis? Findings from the IPF job exposures case-control study. Occup Environ Med. 2023 Feb;80(2):97-103. doi: 10.1136/oemed-2022-108404. Epub 2023 Jan 12.
PubMed 36635100
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pulmonary Fibrosis Job Exposures Study
- ClinicalTrials.gov ID
- NCT03211507
- Acronym / sponsor ID
- IPFJES / 16SM3627
- Conditions
- IPF, Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- 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
- Study start
- 1 May 2017 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Computer-assisted telephone interview, Genetic: Genetic analysisMales with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019. |
| Controls | – | Other: Computer-assisted telephone interview, Genetic: Genetic analysisMales 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital based
Key inclusion criteria (2 listed)
- New diagnosis of IPF between February 2017 and October 2019
- New outpatient department attendee between February 2017 and October 2019
Key exclusion criteria (6 listed)
- Unable to give informed consent
- Ever worked outside of the UK
- For controls
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted telephone interviewOccupational history | Other | Case, Controls |
| Genetic analysisTo include analysis of known susceptibility markers | Genetic | Case, Controls |
Primary outcome
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
2 secondary outcomes
Dose-response relationship between asbestos exposure and IPF
Time frame: 2 years
Gene-environment interaction (for MUC5B rs35705950 and asbestos exposure) odds ratio.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 36635100Reynolds CJ, Sisodia R, Barber C, Moffatt M, Minelli C, De Matteis S, Cherrie JW, Newman Taylor A, Cullinan P. What role for asbestos in idiopathic pulmonary fibrosis? Findings from the IPF job exposures case-control study. Occup Environ Med. 2023 Feb;80(2):97-103. doi: 10.1136/oemed-2022-108404. Epub 2023 Jan 12.
- Full study documentationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Reynolds study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IPF and Idiopathic Pulmonary Fibrosis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between asbestos exposure and IPF (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.