An Italian Randomized Trial for the Evaluation of the Efficacy of Lung Cancer Screening With Low Dose Computed Tomography. The ITALUNG Study.

ITALUNG is a RCT for the evaluation lo the efficacy of lung cancer screening with low-dose CT carried out in three screening centers in Florence, Pisa and Pistoia districts of the Tuscany region of Italy. The study was completely funded by the Regional Health Public Authority and approved by the Local Ethic Committee of each participating institution.

The study involves 269 general practitioners (GPs) operating in the 3 districts, one screening centre for each district, where CT scans and clinical management are performed, and the Institute for Cancer Prevention Research (CSPO) of Florence as a coordinating centre.

Methods The base for subject recruitment was the list of subjects in the 55-69 years range resident in one of the 3 districts where the screening centres are located and registered with one of the GPs who has accepted to participate in the study. These subjects received a letter signed by their GP and by the local screening centre in which the aims and characteristics of the study were explained and a standardized multiple choices questionnaire about age, gender, smoking history, and general health information were enclosed. The candidates were asked to sign their consent of being randomized and to send the letter back to the coordinating centre by mail, free of charge, or to give the questionnaire back to his/her GP. Only subjects registered with participating GPs who gave the letter back with the consent to the randomization were enrolled in the trial.

The consent to be enrolled and randomized was contained in the initial mailing as the consent to be followed up by the GP. All respondents signed the consent before knowing their eligibility and randomization status.

Eligible for the study were subjects aged between 55 and 69 years at the time of enrolment with a smoking history of at least 20 packs-year since the last 10 years (former smokers who quitted since more than 10 years were excluded). Other exclusion criteria were a history of previous cancer other than non-melanoma skin cancer and general conditions precluding thoracic surgery. Eligible subjects only were centrally randomised by a software procedure in an active arm receiving annual low-dose CT for 4 years and a control arm receiving usual care but no screening. Subjects randomized in the control arm then received a letter communicating their allocation in the no screening arm of the study and an invitation for a free access to a smoking cessation program.