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.

The University of Queensland0 sites1,000 target enrollmentStarted: May 30, 2022Last updated: September 9, 2024

Conditions

Trial Snapshot

No summary available.

•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
•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.

•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.
•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.

Sponsor