The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Interventional pilot study, single-center with additional procedures, such as completion of EORTC-QLQ-LC29, EORTC-QLQ-C30 questionnaires, motivational test, Fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, Low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml. The study has the main objective of traininig and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types. The study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this Institute.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
2,840
The radiological investigation will be done with multi-detector-row (64 or more) computed tomography (CT) scanners at low-dose protocol. The low-dose spiral CT consists of a CT study of the chest, without the need for injection of contrast medium, characterized by less radio exposure than the standard CT of the chest with high sensitivity in detecting pulmonary nodules.
Peripheral venous blood sampling (20 ml)
sampling of tumor and healthy tissue during surgery
Scientific Institute Ospedale San Raffaele
Milan, Italy
RECRUITINGCreation of Artificial Intelligence (AI) algorithm
To train and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types. AUC (Area Under the Curve) values, expressed as mean and standard deviation (SD), comparing the ability in detecting the presence of nodules and differentiating the malignancy or benignity of a radiologist versus an AI algorithm, both trained on the same patient group.
Time frame: from enrollment to 48 months
Multimodal program
Develop a multimodal program to enhance the prevention and the early detection of multiple smoking-related diseases Presence and absence of lung nodules \> 4 mm with computed tomography (CT) scan
Time frame: from enrollment to 48 months
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Spirometry measurement using spirometer
Compilation of epidemiological questionnaire, quality of life questionnaires
Study guarantee valid support for quitting smoking, which for a smoker is a more effective intervention to reduce the risk of developing lung cancer, myocardial infarction and other smoking-related diseases
Measurment of Carbon monoxide (CO)
Intervention done in order to find the presence of coronary calcifications