Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001627842
Ethics application status
Approved
Date submitted
2/07/2021
Date registered
29/11/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Western Australia Asbestos Review Program
Scientific title
Western Australia Asbestos Review Program: medical follow up of West Australians exposed to asbestos
Secondary ID [1] 304683 0
None
Universal Trial Number (UTN)
U1111-1267-5069
Trial acronym
ARP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asbestos related diseases 322660 0
lung cancer 322661 0
mesothelioma 322662 0
Pneumoconiosis 322930 0
Condition category
Condition code
Respiratory 320273 320273 0 0
Other respiratory disorders / diseases
Cancer 320506 320506 0 0
Lung - Mesothelioma
Cancer 320507 320507 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A two hour annual review at of persons exposed to asbestos during work or otherwise including general health and specific respiratory questionnaire, blood draw for biomarkers and DNA and lung function followed by ultra-low dose computed tomography (CT) imaging of the chest.
Anticipated duration of follow annual up is up to 30 years although participants may choose to continue after this time.
Annual reviews and prospective data collection have occured since 1990. There is no retrospective data collection.
Intervention code [1] 321056 0
Early Detection / Screening
Intervention code [2] 321225 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328129 0
The number of participants diagnosed with lung cancer.
Data collated from prospective clinical records and histopathology, with confirmation from record linkage to state cancer registry.
Timepoint [1] 328129 0
Up to 30 years post enrolment. Periodic (likley 5 yearly) formal review and linkage with ad hoc analyses throughout.
Primary outcome [2] 328130 0
The number of participants diagnosed with mesothelioma
Data collated from prospective clinical records and histopathology, with confirmation from record linkage to state cancer registry.
Timepoint [2] 328130 0
Up to 30 years post enrolment. Periodic (likley 5 yearly) formal review and linkage with ad hoc analyses throughout.
Primary outcome [3] 328338 0
The number of participants diagnosed with asbestos related lung diseases
Data collated from prospective clinical records and CT reports, with confirmation from record linkage to hospital morbidity records.
Timepoint [3] 328338 0
Up to 30 years after enrolment. Periodic (likley 5 yearly) formal review and linkage with ad hoc analyses throughout.
Secondary outcome [1] 397770 0
The identification of genomic markers associated with asbestos related diseases.
Analyses will include GWAS and more targetted SNP studies using known and supected associated varaints.
Timepoint [1] 397770 0
Up to 30 years after enrolment. Periodic analyses dependent on funding and collaborative projects. Likely at least every 2-3 years.
Secondary outcome [2] 397771 0
The identification of metabolomic biomarkers associated with asbestos related diseases.
Analyses will include assays for known and suspected biomarkers for associated conditions and exploratory analyses for new biomarkers.
Timepoint [2] 397771 0
30 years after enrolment. Periodic analyses dependent on funding and collaborative projects. Likely at least every 2-3 years.
Secondary outcome [3] 403278 0
The risk associated with asbestos exposure and development of malignant and benign asbestos related diseases.
Formal epidemiological review every ~10 years after cancer registy and hopsital episode morbidity linkage.
Timepoint [3] 403278 0
Up to 30 years after recrutiment.

Eligibility
Key inclusion criteria
Women and men who fulfil one or more criteria:
• Minimum of 3 months cumulative exposure to asbestos
• Any Wittenoom resident/worker and/or
• Evidence of asbestos related disease on radiological imaging
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• <16 years of age
• Unstable or untreated medical condition that requires intervention or management
• Unable to attend annual appointments or comply with the study requirements

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There is no primary statistical based outcome for this prospective observational cohort.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/1990
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6000
Accrual to date
5002
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19906 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 34606 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 309051 0
Government body
Name [1] 309051 0
WA Department of Health
Country [1] 309051 0
Australia
Funding source category [2] 309056 0
Government body
Name [2] 309056 0
NH&MRC
Country [2] 309056 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 309993 0
None
Name [1] 309993 0
n/a
Address [1] 309993 0
n/a
Country [1] 309993 0
Other collaborator category [1] 281905 0
University
Name [1] 281905 0
University of Western Australia
Address [1] 281905 0
35 Stirling Highway
Crawley
WA
6009
Country [1] 281905 0
Australia
Other collaborator category [2] 281906 0
University
Name [2] 281906 0
Curtin University
Address [2] 281906 0
Kent Street
Bentley
WA
6102
Country [2] 281906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308927 0
University of Western Australia Human Ethics
Ethics committee address [1] 308927 0
University of Western Australia
35 Stirling Highway
Crawley
WA
6009
Ethics committee country [1] 308927 0
Australia
Date submitted for ethics approval [1] 308927 0
01/06/1989
Approval date [1] 308927 0
01/02/1990
Ethics approval number [1] 308927 0
RA/4/1/2119

Summary
Brief summary
This is a longitudinal observational study that will monitor the health of Western Australians who have been exposed to asbestos through an annual clinical review.

Who is it for?
You may be eligible for this study if you are a resident of Western Australia aged 16 years or older, you are an asbestos exposed ex-worker and/or ex-resident of Wittenoom (the asbestos mine), or if you are an individual with more than 3 months cumulative asbestos exposure and/or radiological evidence of asbestos related disease.

Study details
All participants who choose to enrol in this study will be asked to undergo a general and lung health assessment, lung function tests and an ultra-low dose CT scan of the chest to look for lung disease from asbestos. The Western Australian Asbestos Review Program (ARP) also performs blood tests to see if we can find markers of lung disease to help diagnose problems earlier. Each of these investigations will be completed annually, the appointment usually takes about two hours. The ARP has no limit on age or how long it is since first exposure to asbestos – the study aims to follow as many people exposed to asbestos for as long as possible.

It is hoped this research will provide important information that will allow clinicians to further characterise, diagnose and understand asbestos-related diseases. This information may then be used to improve health outcomes of future patients who have been affected by asbestos exposure.
Trial website
https://www.resphealth.org.au/units/occupational-and-respiratory-health/
Trial related presentations / publications
Public notes
The ARP was established as an interventional study in 1990 as the Vitamin A program. It has run and prospectivley recruited since this time changing its name to the Asbestos Review Program in 2009.

Contacts
Principal investigator
Name 112370 0
Prof Fraser Brims
Address 112370 0
Respiratory Medicine Department
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 112370 0
Australia
Phone 112370 0
+61478598648
Fax 112370 0
Email 112370 0
[email protected]
Contact person for public queries
Name 112371 0
Prof Fraser Brims
Address 112371 0
Respiratory Medicine Department
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 112371 0
Australia
Phone 112371 0
+61478598648
Fax 112371 0
Email 112371 0
[email protected]
Contact person for scientific queries
Name 112372 0
Prof Fraser Brims
Address 112372 0
Respiratory Medicine Department
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 112372 0
Australia
Phone 112372 0
+61478598648
Fax 112372 0
Email 112372 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics permission for this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12395Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AILung cancer screening an asbestos exposed population: Existing lung cancer risk criteria are not sufficient2023https://doi.org/10.1111/resp.14487
N.B. These documents automatically identified may not have been verified by the study sponsor.