Author of

• 17842

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  P2.06 - Poster Session with Presenters Present (ID 467)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17880

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    P2.06-038 - An RCT of the Detection of Autoantibodies to Tumour Antigens in Lung Cancer Using the EarlyCDT-Lung Test in Scotland (ECLS) in 12 208 Study Subjects (ID 4546)

    14:30 - 14:30  |  Author(s): L. Ritchie
    • Abstract

    Background:
    The majority (around 80%) of cases of lung cancer 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 with a specificity of 93% 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 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? We have completed recruitment with 12 208 study subjects randomised by June 2016.
    
    Methods:
    A randomised controlled trial in general practices serving areas of Scotland representing the most socially disadvantaged quintile based on Scottish Index of Multiple Deprivation. Adults aged 50 to 75 at high risk for lung cancer (>20 pack years) 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 have been offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray was used to determine the speed and the need for contrast in the first screening CT. Participants who were found to have lung cancer are being followed-up to assess both time to diagnosis and stage of disease at diagnosis.
    
    Results:
    575/ 6 120 (9.8%) of the test group had a positive test with 207 found to have lung nodules > 8mm. 16 lung cancers have been detected, 12(75%) of which are early stage and 11 abnormalities are undergoing further investigation. At this stage of the trial we have no outcome data for the comparison group.
    
    Conclusion:
    The study will determine the EarlyCDT-Lung test’s clinical and cost effectiveness. It will also assess potential morbidity arising from the test and potential harms and benefits of EarlyCDT-Lung test screening.