Computed tomography (CT) scan low dose: 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.
Tissue sampling (lung): sampling of tumor and healthy tissue during surgery
Spirometry: Spirometry measurement using spirometer
Questionnaires: Compilation of epidemiological questionnaire, quality of life questionnaires
Smoking cessation program: 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
Carbon monoxide measurment: Measurment of Carbon monoxide (CO)
Cardiovascular primary prevention: Intervention done in order to find the presence of coronary calcifications
Study summary
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Creation of Artificial Intelligence (AI) algorithm — from enrollment to 48 months 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.
Trial sites (1)
Facility
City
Region
Status
Scientific Institute Ospedale San Raffaele
Milan
Italy
Recruiting
More Scientific Institute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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