Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001305617
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
14/12/2023
Date last updated
30/05/2024
Date data sharing statement initially provided
14/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Lung Screen Trial for people at risk of developing lung cancer living in diverse geographic and socioeconomic Australian locations.
Scientific title
Australian Lung Screen Trial (ALST) for people at risk of developing lung cancer living in diverse geographic and socioeconomic Australian locations.
Secondary ID [1] 305859 0
ACCR-0000000138
Secondary ID [2] 309932 0
ACRF 001272
Secondary ID [3] 309933 0
MRF000275
Universal Trial Number (UTN)
Trial acronym
ALST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 324406 0
Condition category
Condition code
Cancer 321885 321885 0 0
Lung - Non small cell
Cancer 321886 321886 0 0
Lung - Small cell
Public Health 328669 328669 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.
While there is no specific bio-specimen donation requested in the ALST trial, any Trial Participants who live in or near the Metro North HHS and local area may choose to be invited for donation to the existing The Prince Charles Hospital Lung Bank (Ethics approval: HREC 17/QPCH/54).
Intervention code [1] 322253 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329638 0
Comparing lung cancer screening uptake in at risk people from a range of geographic and socioeconomic communities 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] 329638 0
At enrolment
Primary outcome [2] 329639 0
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 [2] 329639 0
At eligibility assessment prior to enrolment
Secondary outcome [1] 403255 0
Eq5D Quality of Life measurement to measure Quality of Life during the course of the study
Timepoint [1] 403255 0
At study commencement and annually for 10 years
Secondary outcome [2] 423193 0
Costs of screening will be estimated from linkage to Service Australia for Medical Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) item usage after enrollment in the trial
Timepoint [2] 423193 0
4 years after trial enrolment
Secondary outcome [3] 428018 0
Evaluate composite outdoor and household air pollution as a lung cancer risk factor using a exposure questionnaire. The questionnaire is adapted from the Lung Health Questionnaire, used in the International Lung Screen Trial
Timepoint [3] 428018 0
within 3 months post-enrollment
Secondary outcome [4] 428019 0
Uptake rate of invitation to participate in optional bio-specimen donation for future research studies as measured by proportion of Participants who take up the invitation. The number of participants who take up the invitation to participate will be collected from the Eligibility questionnaire, the number of participants who consented, and analysis of data collected on REDCap.
Timepoint [4] 428019 0
within 6 months post-enrollment.
Secondary outcome [5] 428020 0
Effect of smoking cessation interventions using routine smoking cessation brief and offer to refer to Quitline will be assessed by means of self-reported smoking status using a questionnaire annually for 10 years. The Annual Health Assessment questionnaire was adapted from the International Lung Screen Trial Followup questionnaire.
Screening presents an opportunity for health education and thus smoking cessation is an important and integral component of the trial. Regardless of acceptance or not of the screening invitation all current smokers will be offered standardised, culturally appropriate smoking cessation resources e.g. Quitline, State and Commonwealth programs. Participants can also choose to receive information from the research team on other lung cancer research studies by way of a Yes/No statement on the Participant Information and Consent Form. Trial participants may also choose to be invited for the Screen2Quit trial (PI Henry Marshall). ACTRN 12622000990729. The Screen2Quit is not covered in this registration form as it is already registered.
Timepoint [5] 428020 0
Annually for 10 years post-enrolment,

Eligibility
Key inclusion criteria
Male and Female

Aged 50-80 years.

ECOG performance status of 0 or 1

Capable of providing, informed consent for screening procedures (low dose spiral CT)

Meets the PLCOm2012 criteria with risk score equal to or greater than 1.51% over 6 years, aged 55 to 74 years, or Australian Medical Services Committee (MSAC) criteria 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, or US Preventative Services Task Force (USPSTF) criteria of Adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or quit within the past 15 years
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 due to gross obesity.

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 provide 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 CI 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
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
6/03/2024
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
4/12/2034
Actual
Sample size
Target
1500
Accrual to date
77
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21176 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 36040 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 310211 0
Government body
Name [1] 310211 0
National Health and Medical Research Centre
Country [1] 310211 0
Australia
Funding source category [2] 310212 0
Charities/Societies/Foundations
Name [2] 310212 0
Cancer Council Queensland
Country [2] 310212 0
Australia
Funding source category [3] 314113 0
Charities/Societies/Foundations
Name [3] 314113 0
Australian Cancer Research Foundation
Country [3] 314113 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Cumbrae Stewart Building, St Lucia, Brisbane, Queensland 4067
Country
Australia
Secondary sponsor category [1] 311305 0
None
Name [1] 311305 0
Address [1] 311305 0
Country [1] 311305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309893 0
Metro North HREC B
Ethics committee address [1] 309893 0
Ethics committee country [1] 309893 0
Australia
Date submitted for ethics approval [1] 309893 0
05/07/2023
Approval date [1] 309893 0
05/10/2023
Ethics approval number [1] 309893 0
HREC/2023/MNHB/99589

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115750 0
Prof Kwun Fong
Address 115750 0
Department of Thoracic Medicine, Level 2, Administration Building, The Prince Charles Hospital, Rode Road, Chermside, Queensland 4032
Country 115750 0
Australia
Phone 115750 0
+61 7 3139 4314
Fax 115750 0
Email 115750 0
[email protected]
Contact person for public queries
Name 115751 0
Barbara Page
Address 115751 0
Department of Thoracic Medicine, Level 2, Administration Building, The Prince Charles Hospital, Rode Road, Chermside, Queensland 4032
Country 115751 0
Australia
Phone 115751 0
+61 7 3139 4157
Fax 115751 0
Email 115751 0
[email protected]
Contact person for scientific queries
Name 115752 0
Kwun Fong
Address 115752 0
Department of Thoracic Medicine, Level 2, Administration Building, The Prince Charles Hospital, Rode Road, Chermside, Queensland 4032
Country 115752 0
Australia
Phone 115752 0
+61 73139 4000
Fax 115752 0
Email 115752 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


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.