Design, recruitment and baseline results of the ITALUNG trial for lung cancer screening with low-dose CT

Background: Results of randomized clinical trials (RCTs) are needed to assess the efficacy of lung cancer screening with low-dose chest computed tomography (CT) in reducing lung cancer mortality. We report design and results of enrolment and baseline Screening test in the ITALUNG trial, a RCT. Methods: Invitation letters were sent to subjects of 55-69 years of age clients of 269 general practitioners. Smokers Or former smokers of at least 20 pack/years were eligible and after written consent were randomized in an active arm undergoing a low-dose CT annually for 4 years and in a control arm receiving no screening. Management of positive screening test was carried out using follow-up low-dose CT fluorodeoxyglucose positron emission tomography, fine needle aspiration cytology and fiber optic bronchoscopy. Results: A sample of 3206 eligible subjects was achieved by sending 71,232 letters (enrolment efficacy = 4.5%). Subjects in Control (n = 1593) and active (n = 1613) arm were balanced for age, gender and smoking history. Two-hundred and seven (12.8%) Subjects did not undergo CT after randomization. The baseline screening test was positive in 426 (30.3%) of 1406 subjects. (C) 2008 Elsevier Ireland Ltd. All rights reserved.