Overview
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Description
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.
Eligibility
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