Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000586516
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
8/05/2024
Date last updated
8/05/2024
Date data sharing statement initially provided
8/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Lung Screen Trial for Aboriginal and Torres Strait Islander Peoples
Scientific title
Australian Lung Screen Trial for Aboriginal and Torres Strait Islander Peoples at risk of developing lung cancer a study evaluating the impact of addressing the cultural aspects of lung cancer screening on uptake and completion of screening.
Secondary ID [1] 309844 0
MRF2007230
Secondary ID [2] 309931 0
ACCR-0000000138
Secondary ID [3] 309936 0
ACRF 001272
Universal Trial Number (UTN)
Trial acronym
ALST FN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 330279 0
Condition category
Condition code
Cancer 327143 327143 0 0
Lung - Non small cell
Cancer 327144 327144 0 0
Lung - Small cell
Public Health 328999 328999 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low dose CT chest scan screening for people at high risk of lung cancer who meet screening eligibility criteria
A low dose CT scan which usually has a radiation dose of about 1.5mSv will be provided by registered Medical Imaging Providers by their Radiographers and Radiologists in accordance to their Standard Operating Procedures. The dose of radiation will be monitored for each scan. The scan does not involve contrast and may take 10-15 minutes to complete..
Intervention code [1] 326279 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335016 0
Comparing lung cancer screening uptake in at risk Aboriginal and Torres Strait Islander peoples with fixed CT scanners or a mobile lung cancer screening platform. Data will be sourced from radiology records and demographic data from eligibility questionnaire.
We will calculate the number of eligible participants who complete a low dose CT stratified by residence (metropolitan, rural or remote) and by fixed or mobile CT scanners.
Timepoint [1] 335016 0
3 months after enrolment
Primary outcome [2] 335110 0
Comparing lung cancer screening uptake in at risk Aboriginal and Torres Strait Islander Peoples recruited through a GP practice using the Medicare 715 health check to self-referred recruitment. Data will be sourced from REDCap.
We will calculate the number of people who complete the eligibility questionnaire with their GP, or health worker while undergoing their 715 Health Check and the number of people who self-complete the eligibility questionnaire.
Timepoint [2] 335110 0
At eligibility assessment prior to enrolment
Primary outcome [3] 336790 0
Risk prediction models
Comparing the Prostate Lung Colon Ovary (PLCO)m2012 risk prediction model to the Medical Services Advisory Committee (MSAC) criteria for screening and the US Preventative Services TaskForce criteria for screening eligibility and lung cancer detection.
Data used for PLCOm2012 and MSAC will be collected from the Eligibility questionnaire.
We will compare the eligibility rate for Participants by each of these criteria.
Timepoint [3] 336790 0
At eligibility assessment prior to enrolment
Secondary outcome [1] 422714 0
Composite secondary outcome:
Uptake and acceptability of smoking cessation (number and proportion of individuals who are smokers, former and current, smoking individuals willing to quit, current smoking individuals able to quit), cessation rates using health questionnaires, Lung Health Questionnaire (LHQ) and Annual Health Questionnaire (AHA). Both the LHQ and the AHA were adapted from the International Lung Screen Trial questionnaires.
Timepoint [1] 422714 0
Annually for up to 10 years post enrolment
Secondary outcome [2] 423178 0
Composite secondary outcome:
Utilisation rates for interval scans: including PET scans, diagnostic biopsies, surgery, tumour stage, treatments, physical and mental health adverse events.
Method of assessment:
PET scans, diagnostic biopsies, surgery, tumour stage treatments - electronic medical records
Physical and mental health adverse events - quality-of-life questionnaire, EQ5D QoL.
Incidental conditions: Annual Health Assessment questionnaire.
Timepoint [2] 423178 0
Annually for up to 10 years post enrolment
Secondary outcome [3] 428021 0
CT metrics: radiation dose
number of suboptimal scans
This will be assessed as a composite outcome.
Timepoint [3] 428021 0
12 months after enrolment
Secondary outcome [4] 428022 0
costs; financial and time cost to participation in screening by measuring usage of MBS and PBS (Pharmaceutical Benefits Scheme) for the evaluation of health care costs about 5 years after enrolment
Timepoint [4] 428022 0
5 years after enrolment
Secondary outcome [5] 434415 0
Computer Aided Diagnosis (CAD) Vs Human performance:
concordance rates for nodule and cancer detection,
3D volumetry compared to conventional 2D linear measurements of nodules)
Timepoint [5] 434415 0
12 months after enrolment

Eligibility
Key inclusion criteria
Aboriginal and Torres Strait Islander people who are generally fit and well
Aboriginal and Torres Strait Islander people aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or quit within the past 15 years (2021 US Preventative Services Task Force (USPSTF) criteria).
Aboriginal and Torres Strait Islander people aged 50 to 70 years who have a history of cigarette smoking of at least 30 pack years, and, if former smokers, quit within the previous 10 years (Medical Services Advisory Committee (MSAC) criteria).
Aboriginal and Torres Strait Islander people assessed as having a PLCOm2012 lung cancer risk score assessment of more than 1.5 percent over 6 years.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical symptoms suspicious for lung cancer e.g., haemoptysis, chest pain, weight loss.
Any medical condition, such as severe heart disease (e.g., unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen
therapy, bleeding disorder, that in the opinion of the investigator could jeopardize the subject’s safety during participation in the study or unlikely to benefit from
screening due to shortened life-expectancy from the co-morbidities.
Have been previously diagnosed with lung cancer.
Have had other non-curatively treated cancer outside the lung.
Pregnancy
Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks.
Unwilling to have a spiral chest CT.
Chest CT within 2 years
Does not fit into CT scanner table.
Cannot lie on CT scanning table on the back with arms over the head.
Received chemotherapy or cytotoxic drugs within the last 6 months.
Unwilling to sign a consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Biostatistics: Support is provided by Professor Martin Tammemagi and the Statistical Services provided by the University of Queensland and Metro North Hospital and Health Services (QIMR Berghofer). The statistical analysis will calculate the specified study outcomes using logistic regression to control for group and individual level covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/12/2036
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,WA,VIC
Recruitment hospital [1] 24934 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 24935 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [3] 24936 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 24937 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [5] 24938 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [6] 24939 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [7] 24946 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [8] 24947 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 40588 0
0810 - Tiwi
Recruitment postcode(s) [2] 40590 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 40589 0
2830 - Dubbo
Recruitment postcode(s) [4] 40586 0
3052 - Parkville
Recruitment postcode(s) [5] 40597 0
3128 - Box Hill
Recruitment postcode(s) [6] 40585 0
4032 - Chermside
Recruitment postcode(s) [7] 40598 0
6009 - Nedlands
Recruitment postcode(s) [8] 40587 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 314031 0
Government body
Name [1] 314031 0
NHMRC
Country [1] 314031 0
Australia
Funding source category [2] 314112 0
Charities/Societies/Foundations
Name [2] 314112 0
Cancer Council Queensland
Country [2] 314112 0
Australia
Funding source category [3] 314116 0
Charities/Societies/Foundations
Name [3] 314116 0
Australian Cancer Research Foundation
Country [3] 314116 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
UQ Research and Innovation Cumbrae - Stewart Building St Lucía Queensland 4067
Country
Australia
Secondary sponsor category [1] 316014 0
None
Name [1] 316014 0
Address [1] 316014 0
Country [1] 316014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313165 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 313165 0
MSH Research Translational Research Institute (PAH Campus) | Metro South Health Woolloongabba Queensland 4102
Ethics committee country [1] 313165 0
Australia
Date submitted for ethics approval [1] 313165 0
14/09/2023
Approval date [1] 313165 0
28/11/2023
Ethics approval number [1] 313165 0
HREC/2023/QMS/102326

Summary
Brief summary
This Study aims to understand the best way to offer Australian Aboriginal and Torres Strait Islander Peoples lung cancer screening.
Who is it for?
You may be eligible to join this study if you are an Aboriginal or Terres Strait Islander person aged between 50 to 80 years old, and at high risk for developing lung cancer.

Study details.
All participants who complete an eligibility questionnaire and are found to be at high risk of developing lung cancer will be offered a low dose CT chest scan.
Participants will be invited to complete a Lung Health Questionnaire, a Quality-of-Life questionnaire on enrolment then an annual health assessment questionnaire for up 10 years.
Participants who do not meet the eligibility criteria for a low dose CT chest scan will be invited to participate in the Annual Health Assessment by agreeing to complete a questionnaire every year for up to 10 years.
It is hoped that this research project will contribute to lung cancer screening research to detect lung cancer so it can be treated early.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127218 0
Prof Kwun Fong
Address 127218 0
Department of Thoracic Medicine Level 2 Administration Building The Prince Charles Hospital Rode Road Chermside Queensland 4032
Country 127218 0
Australia
Phone 127218 0
+61 07 3139 4314
Fax 127218 0
Email 127218 0
kwun.fong@health.qld.gov.au
Contact person for public queries
Name 127219 0
Dr Barbara Page
Address 127219 0
Department of Thoracic Medicine Level 2 Administration Building The Prince Charles Hospital Rode Road Chermside Queensland 4032
Country 127219 0
Australia
Phone 127219 0
+61 07 3139 4157
Fax 127219 0
Email 127219 0
barbara.page@health.qld.gov.au
Contact person for scientific queries
Name 127220 0
Prof Kwun M Fong
Address 127220 0
Department of Thoracic Medicine Level 2 Administration Building The Prince Charles Hospital Rode Road Chermside Queensland 4032
Country 127220 0
Australia
Phone 127220 0
+61 07 3139 4314
Fax 127220 0
Email 127220 0
kwun.fong@health.qld.gov.au

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.