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Trial registered on ANZCTR


Registration number
ACTRN12622000770763
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
30/05/2022
Date last updated
1/09/2024
Date data sharing statement initially provided
30/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Lung Screen Trial (ALST): lung cancer screening with low dose computerised tomography (CT) scans in light/never smokers
Scientific title
Australian Lung Screen Trial: Feasibility and lung cancer detection rate of low dose computerised (CT) scans for people who have no smoking or a light smoking history, and are at risk of developing lung cancer.
Secondary ID [1] 306348 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ALST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer
325150 0
Condition category
Condition code
Cancer 322554 322554 0 0
Lung - Non small cell
Cancer 322555 322555 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate whether risk prediction model(s) can identify people at high risk of lung cancer who do not meet current screening eligibility criteria, to undertake lung cancer screening.
• An adapted aPLCOall2014 model for light / never smokers (Tammemägi MC, Church TR, Hocking WG, Silvestri GA, Kvale PA, Riley TL, et al. (2014) Evaluation of the Lung Cancer Risks at Which to Screen Ever- and Never-Smokers: Screening Rules Applied to the PLCO and NLST Cohorts. PLoS Med 11(12): e1001764 https://doi.org/10.1371/journal.pmed.1001764) which incorporates known risk predictors for never smokers developing lung cancer (age, family history of lung cancer, personal history of cancer, secondhand smoke, indoor / outdoor air pollution, exposures to environmental or occupational lung carcinogens and inflammatory pulmonary diseases).
• Individuals with predicted lung cancer/6-year risk of >0.0151 risk threshold, are deemed eligible and offered a low dose CT scan to screen for lung cancer.
Eligible participants will attend a radiology service for the low dose CT scan. The participant will be instructed to lie on an x-ray table with their arms above their head and to hold their their breath for 5 - 10 seconds while the table moves through the CT scanner. The procedure will take less than 10 minutes.
A radiographer who is suitably qualified in CT scanning protocols, will administer the CT scan and a specialist radiologist will assess the films and complete a synoptic report. The scan results will be provided to the participant and their primary care provider for appropriate management.
If a nodule is detected on the CT, a followup scan will be offered dependent on the risk of developing lung cancer e.g. 12 months for low risk, and 3 months for moderate risk. If the participant is assessed as high risk of developing lung cancer, they will be referred to a lung specialist for further investigations.
For enrolled participants who are not eligible for CT screening they will be offered to participate in annual online questionnaires about their health status including current comorbidities, new health conditions, medications, quality of life and bone health. There may be more than one online questionnaire and each may take 10-15 minutes to complete.
Intervention code [1] 322780 0
Early Detection / Screening
Intervention code [2] 323415 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330349 0
The feasibility of using adapted risk prediction models, aPLCOall2014 for never smokers and aPLCOm2012 for light smokers to identify eligible participants for CT screening will be assessed as the proportion of interested participants who meet the risk model threshold.
Timepoint [1] 330349 0
The outcome will be assessed after eligibility assessment using the risk models.
Primary outcome [2] 330351 0
Proportion of participants who either meet or do not meet screening model selection criteria and are diagnosed with lung cancer in the subsequent 10 years.
Timepoint [2] 330351 0
Annually, with health questionnaires as used in the ILST and linkage to Cancer and Death Registries for lung cancer status after 4 years follow-up
Primary outcome [3] 330352 0
Impact of thrombocytosis +/- blood cancer biomarkers on the development of lung cancer in the following 10 years for participants enrolling in the trial.
Timepoint [3] 330352 0
Annually, with health questionnaires as used in ILST and linkage to Cancer and Death Registries for lung cancer status after 4 years follow-up
Secondary outcome [1] 405917 0
Evaluation of quality of life and health status of participants. Quality of Life (QOL) EQ5D5L a and/or Health Status questionnaires as used in the ILST will be invited at the start of the study and annually.
Timepoint [1] 405917 0
1 year after entry to study and annually for 10 years post enrolment.
Secondary outcome [2] 408988 0
Costs of screening will be estimated from linkage to Service Australia for MBS and PBS item usage after enrollment in the trial
Timepoint [2] 408988 0
Beyond 4 years after trial enrolment
Secondary outcome [3] 408989 0
Evaluate outdoor and household air pollution as a lung cancer risk factors using a exposure questionnaire (LHQ) as used in ILST
Timepoint [3] 408989 0
After enrollment.within 6 months
Secondary outcome [4] 408991 0
Uptake rate of invitation to participate in optional bio-specimen donation for future research studies
Timepoint [4] 408991 0
12 months after enrollment.
Secondary outcome [5] 408993 0
Effectiveness of smoking cessation interventions., by self reported smoking status health status questionnaire as used in ILST
Timepoint [5] 408993 0
Annually for 10 years post-enrolment,
Secondary outcome [6] 408995 0
Validated surrogate measures of lung cancer diagnosis assessed by Quality of Life questionnaires completed by all participants whether they received CT screening or were ineligible.
The QOL questionnaire will be administered Post Enrolment and annually for 10 years and was adapted from the International Lung Screen Trial Annual Followup Questionnaire
Timepoint [6] 408995 0
1 year after entry to study and annually for 10 years post-enrolment.

Eligibility
Key inclusion criteria
Eligibility Criteria for Low Dose CT scan
Inclusion Criteria
• Women or men age from 55 to 74.
• Never smokers defined as having smoked less than 100 cigarettes in lifetime
• Current light or former light smoker defined as the number of packs of cigarettes smoked per day by the number of years the person has smoke less than or equal to 20.
• An estimated 6-year lung cancer risk of more than 1.51% by either the aPLCOall2014 and aPLCOm2012 risk prediction models (1,2), or lower if they have thrombocytosis or a positive blood cancer biomarker such as pro-SFTB, CASA, CEA, CYFRA 21-1, NSE, MSA, TPA, and TPS.(3)
• ECOG performance status 0 - Fully active; no performance restrictions.
• ECOG performance status 1 - Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
• Capable of providing, informed consent for screening procedures

References
1. Tammemagi, M.C., et al., Evaluation of the lung cancer risks at which to screen ever- and never-smokers: screening rules applied to the PLCO and NLST cohorts. PLoS Med, 2014. 11(12): p. e1001764.
2. Tammemagi, M.C., et al., Selection criteria for lung-cancer screening. N Engl J Med, 2013. 368(8): p. 728-36.
3. Devine, P., et al., Serum markers casa, cea, cyfra-21-1, msa, nse, tpa and tps in lung-cancer. Int J Oncol, 1994. 4(5): p. 1129-35.
Minimum age
55 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be ineligible to receive CT screening if they meet any of the following criteria.

• Clinical symptoms suspicious for lung cancer e.g. hemoptysis, 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 jeopardise 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 in the last 5 years.
• 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 for cancer within the last 12 months
• Unwilling to provide consent

Participants who do not meet eligibility for CT screening but still satisfy the inclusion criteria will be eligible to participate in the annual 10 year Quality of LIfe and Health Assessment Questionnaires.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
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
1/07/2024
Actual
7/08/2024
Date of last participant enrolment
Anticipated
1/11/2027
Actual
Date of last data collection
Anticipated
30/06/2034
Actual
Sample size
Target
1000
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 21646 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 21647 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 21648 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 21649 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [5] 21957 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 36686 0
3050 - Parkville
Recruitment postcode(s) [2] 36688 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 36689 0
4032 - Chermside West
Recruitment postcode(s) [4] 37050 0
3128 - Box Hill
Recruitment postcode(s) [5] 37051 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 310702 0
Government body
Name [1] 310702 0
NHMRC
Country [1] 310702 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Director, Office of Sponsored Research
Level 1, Cumbrae Stewart Building
72 Research Road St Lucia, Qld 4072
Country
Australia
Secondary sponsor category [1] 312676 0
None
Name [1] 312676 0
Address [1] 312676 0
Country [1] 312676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310285 0
Metro North Human Research Ethics Committee B
Ethics committee address [1] 310285 0
Ethics and Governance Unit
Building 14 The Prince Charles Hospital,
Rode Road, Chermside, Brisbane Queensland 4032
Ethics committee country [1] 310285 0
Australia
Date submitted for ethics approval [1] 310285 0
11/11/2021
Approval date [1] 310285 0
17/02/2022
Ethics approval number [1] 310285 0
HREC/2022/QPCH/79885

Summary
Brief summary
Current guidelines suggest invitation of smokers (current or past) of 20 pack years or more (US Preventative Services Task Force) to participate in lung cancer screening. However, a significant proportion of lung cancers will not be detected by these criteria. Therefore, the aim of this study is to determine the feasibility and lung cancer detection rate of identifying and screening at-risk never/light smokers for lung cancer using personalised risk prediction.

Who is it for?
People aged from 55 to 74 years (inclusive), and have never smoked or are a current/former light smoker.

Study details
Interested participants will be assessed for screening eligibility by completing a questionnaire which incorporates known risk predictors for never smokers developing lung cancer (age, family history of lung cancer, personal history of cancer, secondhand smoke, indoor / outdoor air pollution, exposures to environmental or occupational lung carcinogens and inflammatory pulmonary diseases).
Participants will also be invited to participate in an optional sub-study of blood, breath and body fluid and remnant tissue collection to research novel biopmarkers of lung cancer risk.
Participants determined to have a 6-year lung cancer risk more than 1.51%,will proceed to single low-dose spiral chest computerised tomography (LDCT) scan. The LCDT scan will be examined for any lung nodules, and referral for follow-up treatment provided accordingly.
Participants will also complete a number of Quality of Life and health status questionnaires annually for 10 years post-enrollment.. Participants found ineligible for LDCT will be enrolled into the health questionnaire component of the study for 10 years to determine whether they develop lung cancer during the study period.

It is hoped that this study may show new ways to identify people who may benefit from lung cancer screening. with low dose CT scans..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117122 0
Prof Kwun M Fong
Address 117122 0
Department of Thoracic Medicine,
Level 2 Administration Building,
The Prince Charles Hospital
Rode Road, Chermside, Brisbane Queensland 4032
Country 117122 0
Australia
Phone 117122 0
+61 07 3139 4314
Fax 117122 0
Email 117122 0
[email protected]
Contact person for public queries
Name 117123 0
Barbara Page
Address 117123 0
Department of Thoracic Medicine,
Level 2 Administration Building,
The Prince Charles Hospital
Rode Road, Chermside, Brisbane Queensland 4032
Country 117123 0
Australia
Phone 117123 0
+61 07 3139 4157
Fax 117123 0
Email 117123 0
[email protected]
Contact person for scientific queries
Name 117124 0
Kwun M Fong
Address 117124 0
Department of Thoracic Medicine,
Level 2 Administration Building,
The Prince Charles Hospital
Rode Road, Chermside, Brisbane Queensland 4032
Country 117124 0
Australia
Phone 117124 0
+61 07 3139 4314
Fax 117124 0
Email 117124 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.