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
Scientific Institute San Raffaele
2,840 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
Summary
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Eligibility
Inclusion Criteria14
- High-risk screening subjects
- 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
- 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
- Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
- Signed informed consent
- 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 Criteria11
- 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
- \- None
- Previous high-risk negative screening subjects
- \- None
- Lung Cancer patients
- computed tomography (CT) scans not available at San Raffaele Hospital
- Previous neoadjuvant treatment
Interventions
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
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06626178