RecruitingNot ApplicableNCT06626178

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


Sponsor

Scientific Institute San Raffaele

Enrollment

2,840 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial uses artificial intelligence to help detect and prevent lung cancer and other smoking-related diseases earlier and more accurately. You may be eligible if... - You are 50 years or older - You are a current smoker, or you quit smoking within the last 15 years - You have smoked more than 20 pack-years - Your risk score on the PLCOm2012 model is above 1.2% - OR you were previously in a lung screening program and had lung nodules larger than 4mm, or had a negative CT result - OR you have been diagnosed with (or are suspected of having) lung cancer and are being considered for surgery You may NOT be eligible if... - You have had or currently have any cancer (other than skin cancer) - You have cognitive difficulties that would prevent you from giving consent - You have severe lung or other serious organ disease - You had a low-dose CT scan in the past 12 months - Your CT scans are not available at San Raffaele Hospital - You received pre-surgery cancer treatment (neoadjuvant therapy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTComputed 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.

PROCEDUREBlood sampling

Peripheral venous blood sampling (20 ml)

PROCEDURETissue sampling (lung)

sampling of tumor and healthy tissue during surgery

OTHERSpirometry

Spirometry measurement using spirometer

OTHERQuestionnaires

Compilation of epidemiological questionnaire, quality of life questionnaires

OTHERSmoking 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

OTHERCarbon monoxide measurment

Measurment of Carbon monoxide (CO)

OTHERCardiovascular primary prevention

Intervention done in order to find the presence of coronary calcifications


Locations(1)

Scientific Institute Ospedale San Raffaele

Milan, Italy

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NCT06626178


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