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PRogetto Salute Parma

University of Parma · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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cigarettelung-cancersmokingsmoking-cessationtobacco
This project from the University Hospital of Parma (AOUPR) aims to verify the feasibility of a prevention program in our district, relying on advanced technological resources and highly experienced team in lung cancer early diagnosis, in order to identify useful elements towards the applicability of such a prevention program on a large scale (regional, national). Uncontrolled, monocentric experimental study with dynamic enrollment and prospective data collection, aimed at implementing a prevention program based on scientific evidence. This study is set to verify the applicability and feasibility of a lung cancer prevention program in a real context, including a preliminary evaluation at the smoking cessation clinic and a LDCT assessment with subsequent LDCT follow-up for participants who show indeterminate findings at the first LDCT (LDCT baseline) exam. The main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods. Secondary objectives: 1. To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention) 2. To evaluate the outcomes of the program in terms of number of patients with early (presymptomatic) lung cancer treated with minimally invasive surgery (secondary prevention) 3. To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy) Primary endpoint: \- Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months Secondary endpoints: * To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization * To measure the variation in smoking habits in enrolled smokers * To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and s
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