ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

lung cancer

mesothelioma

Pneumoconiosis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Cancer

Lung - Mesothelioma

Cancer

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]

Early Detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Up to 30 years post enrolment. Periodic (likley 5 yearly) formal review and linkage with ad hoc analyses throughout.

Primary outcome [2]

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]

Up to 30 years post enrolment. Periodic (likley 5 yearly) formal review and linkage with ad hoc analyses throughout.

Primary outcome [3]

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]

Up to 30 years after enrolment. Periodic (likley 5 yearly) formal review and linkage with ad hoc analyses throughout.

Secondary outcome [1]

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]

Up to 30 years after enrolment. Periodic analyses dependent on funding and collaborative projects. Likely at least every 2-3 years.

Secondary outcome [2]

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]

30 years after enrolment. Periodic analyses dependent on funding and collaborative projects. Likely at least every 2-3 years.

Secondary outcome [3]

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]

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?

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)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

WA Department of Health

Address [1]

189 Royal St,
East Perth
WA
6004

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NH&MRC

Address [2]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [2]

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]

None

Name [1]

n/a

Address [1]

n/a

Country [1]

Other collaborator category [1]

University

Name [1]

University of Western Australia

Address [1]

35 Stirling Highway
Crawley
WA
6009

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Curtin University

Address [2]

Kent Street
Bentley
WA
6102

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Australia Human Ethics

Ethics committee address [1]

University of Western Australia 
35 Stirling Highway
Crawley 
WA 
6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/06/1989

Approval date [1]

01/02/1990

Ethics approval number [1]

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

Prof Fraser Brims

Address

Respiratory Medicine Department
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009

Country

Australia

Phone

+61478598648

Fax

fraser.brims@curtin.edu.au

Contact person for public queries

Name

Fraser Brims

Address

Respiratory Medicine Department
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009

Country

Australia

Phone

+61478598648

Fax

fraser.brims@curtin.edu.au

Contact person for scientific queries

Name

Fraser Brims

Address

Respiratory Medicine Department
B Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009

Country

Australia

Phone

+61478598648

Fax

fraser.brims@curtin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No ethics permission for this

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12395	Study protocol			fraser.brims@curtin.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Lung cancer screening an asbestos exposed population: Existing lung cancer risk criteria are not sufficient	2023	https://doi.org/10.1111/resp.14487

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically