NCT03211507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

2.4 years

First QC Date

May 2, 2017

Last Update Submit

December 10, 2019

Conditions

IPFIdiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Association between asbestos exposure and IPF

    estimated using logistic regression for any vs no asbestos exposure and adjusting for age and smoking status

    2 years

Secondary Outcomes (2)

  • Dose-response relationship between asbestos exposure and IPF

    2 years

  • Gene-environment interaction (for MUC5B rs35705950 and asbestos exposure) odds ratio.

    2 years

Study Arms (2)

Case

Males with an incident diagnosis of IPF made between the 1st of February 2017 and the 5th of October 2019.

Other: Computer-assisted telephone interviewGenetic: 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.

Other: Computer-assisted telephone interviewGenetic: Genetic analysis

Interventions

Computer-assisted telephone interviewOTHER

Occupational history

CaseControls
Genetic analysisGENETIC

To include analysis of known susceptibility markers

CaseControls

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospital based

You may qualify if:

  • New diagnosis of IPF between February 2017 and October 2019

You may not qualify if:

  • Unable to give informed consent
  • Ever worked outside of the UK
  • For controls
  • New outpatient department attendee between February 2017 and October 2019
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36635100DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Carl Reynolds

    Imperial College London

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

July 7, 2017

Study Start

May 1, 2017

Primary Completion

October 5, 2019

Study Completion

October 5, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)