NCT06626178

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,840 (estimated)
• Sponsor: Scientific Institute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Lung Cancer Screening Program
• Artificial Intelligence (AI)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
PROCEDURE	Blood sampling	Peripheral venous blood sampling (20 ml)
PROCEDURE	Tissue sampling (lung)	sampling of tumor and healthy tissue during surgery
OTHER	Spirometry	Spirometry measurement using spirometer
OTHER	Questionnaires	Compilation of epidemiological questionnaire, quality of life questionnaires
OTHER	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
OTHER	Carbon monoxide measurment	Measurment of Carbon monoxide (CO)
OTHER	Cardiovascular primary prevention	Intervention done in order to find the presence of coronary calcifications

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2024-10-03
• Last updated: 2024-10-03

Locations

1 site across 1 country: Italy