The EarlyCDT-Lung test is a high-specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. We report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent computed tomography (CT) scanning to identify those at high risk of lung cancer reduces the incidence of patients with stage III/IV/unspecified lung cancer at diagnosis compared with the standard clinical practice at the time the study began.The Early Diagnosis of Lung Cancer Scotland (ECLS) trial was a randomised controlled trial of 12?208 participants at risk of developing lung cancer in Scotland in the UK. The intervention arm received the EarlyCDT-Lung test and, if test-positive, low-dose CT scanning 6-monthly for up to 2 years. EarlyCDT-Lung test-negative and control arm participants received standard clinical care. Outcomes were assessed at 2 years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities.At 2 years, 127 lung cancers were detected in the study population (1.0%). In the intervention arm, 33 out of 56 (58.9%) lung cancers were diagnosed at stage III/IV compared with 52 out of 71 (73.2%) in the control arm. The hazard ratio for stage III/IV presentation was 0.64 (95% CI 0.41-0.99). There were nonsignificant differences in lung cancer and all-cause mortality after 2 years.ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation) and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of low-dose CT.
This paper presumes standard of care for lung cancer detection is simply waiting for symptoms. It is not. The more meaningful study would compare the blood test to annual ct. Over a decade after the NLST, this trial is too small and too late.
A biomarker test like the autoantibody test could potentially play a role in identifying those most at risk and who have the most to gain from a early diagnosis; although, it is not yet clear how long autoantibodies continue to be present once triggered. This pragmatic randomised controlled trial included a CONSORT statement, used informed consent, intention to teat principle, and diagnostic cost. The participants in the intervention arm were diagnosed with lung cancer on average 87.3 days earlier, mean 303.0 days, compared with the control arm mean 390.3 days. However, the screening using the autoantibodies and CT scan would be more costly and not so effective. There were nonsignificant differences in lung cancer and all-cause mortality after 2 years. Maybe it would be useful if used longer.