Australian Lung Screen Trial (ALST): lung cancer screening with low dose computerised tomography (CT) scans in light/never smokers - Trial ANZCTR12622000770763

Timeline & Enrollment

Primary Outcome

Feasibility of using newly adapted PLCO risk prediction models to screen for lung cancer using low dose CT. The feasibility of using the newly adapted risk prediction models, aPLCOall2014) for never smokers and aPLCOm2012 for female light smokers will be assessed as the proportion of participants eligible for screening and have a lung nodule detected on low dose CT screening. scan . The outcome will be assessed once only after low dose scan images have been reported and verified. and compared to the risk prediction model used. . ;; Proportion of participants who do not meet screening selection criteria but develop lung cancer. This outcome will be assessed through a composite method of annual online health questionnaires and data linkage data to Medicare where permission has been obtained. The following validated questionnaires will be used in the study. Baseline Risk Questionnaire (adapted from the International Lung Screen Trial Osteoporosis Questionnaire) Baseline Risk Supplementary Questionnaire (adapted from the International Lung Screen Trial Osteoporosis Questionnaire) Baseline Risk Followup Questionnaire (adapted from the International Lung Screen Trial Osteoporosis Questionnaire) Exhaled Carbon Monoxide (ECO) Breath Test Collection Form (adapted from the International Lung Screen Trial ECO) Health Questionnaire Australian Version EQ-5D-5L adapted from Australia (English) © 2009 Euro Qol Group EQ-5D™ is a trade mark of the Euro Qol Group Lung Health Questionnaire (LHQ) adapted from the International Lung Screen Trial (LHQ) Post Enrolment Annual Followup Questionnaire adapted from the International Lung Screen Trial Annual Followup Questionnaire ;; Cancer detection rate will be assessed by the number of participants screened to detect one cancer on review of the initial and followup CT scans as applicable.

Summary

Current guidelines invite 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 provide a single blood sample to assess platelet levels and cancer biomarkers to incorporate into the risk calculation. 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-enrolment. 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 that this risk prediction model is feasible to implement, and is able to accurately predict those who may benefit from lung cancer screening.

ICD-10 Classifications