Abstract
BackgroundLung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis.The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice?MethodsA randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50–75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0–2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening.Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis.DiscussionThe study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed.Trial registrationNCT01925625. August 19, 2013
Highlights
Lung cancer is the most common cause of cancer related death worldwide
A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Early cancer detection test (Test) study will be developed
To assess the effectiveness of the test in increasing early stage lung cancer detection, thereby reducing the rate of late stage (III/IV/U) presentation compared to standard practice; to assess the cost-effectiveness of the test compared to standard practice; to assess the impact of the test on quality of life, positive and negative affect, illness perceptions, lung cancer risk perception, health anxiety, lung cancer worry, subjective stress related to screening, smoking behaviour and health service use
Summary
Design This is a randomised controlled trial involving 12,000 participants recruited through primary care and community based recruitment strategies in Scotland. < h3 > Setting. Management of the visits Based on the test’s reported 90% specificity and 41% sensitivity we anticipate that 520–550 participants in the intervention arm will have a positive test result These will be offered a chest X-ray in accordance with local requirements for prioritisation and will be referred for a noncontrast thoracic CT scan. Intervention EarlyCDT®-Lung Test blood sample followed by X-ray and serial cross sectional CT imaging in those with a positive result 6 monthly for 24 months Those with a negative test, like the controls, have no further investigations but are provided with standard clinical care. Outcomes Primary The difference, at 24 months after randomisation, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis in the intervention arm, and those in the control arm; Secondary. ➢ EarlyCDT Positive Test Participants may visit or call. ➢ EARLY CDT Negative Test Participants may attend for further information/advice only
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