None listed
Conditions
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..
Interventions
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
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.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
55 Years to 74 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed