Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.

ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases

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.

High-risk screening subjects

Inclusion Criteria:

• Age >= 50 years old
• Active smokers
• Former smokers (from no more than 15 years)
• Pack/year >20
• Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) >1.2%
• Provision and signature of informed consent

Exclusion Criteria:

• Previous or concurrent neoplastic disease, excluding skin cancers
• Cognitive or other problems that could hinder the collection of informed consent
• Severe pulmonary or extra pulmonary disease
• Previous low-dose computed tomography (CT) scan in the past 12 months

Previous high-risk positive screening subjects

Inclusion Criteria:

• Subjects enrolled in previous lung cancer screening with the presence of lung nodules >4 mm and candidate to additional computed tomography (CT)
• Signed informed consent

Exclusion Criteria:

- None

Previous high-risk negative screening subjects

Inclusion Criteria:

• Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
• Signed informed consent

Exclusion Criteria:

- None

Lung Cancer patients

Inclusion Criteria:

• Patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it
• Patients with diagnosis of lung cancer treated with surgical resection
• Signed informed consent

Exclusion Criteria:

• computed tomography (CT) scans not available at San Raffaele Hospital
• Previous neoadjuvant treatment