Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases. (ARIA)

Scientific Institute San Raffaele

Status: Enrolling

Conditions: Lung Cancer Screening Program; Artificial Intelligence (AI)

Treatments: Other: Questionnaires; Other: Carbon monoxide measurment; Diagnostic Test: Computed tomography (CT) scan low dose; Other: Cardiovascular primary prevention; Other: Smoking cessation program; Other: Spirometry; Procedure: Tissue sampling (lung); Procedure: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT06626178

CET 288-2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,840 participants in 4 patient groups

High-risk screening subjects

Experimental group

Description:

Ever and former male and female smokers aged over 50 years old at high risk for lung cancer, cardiovascular diseases and chronic obstructive pulmonary disease (COPD). Additional procedures for this group: * Spirometry * Nurse evaluation * Epidemiological questionnaire, Quality of Life (QoL) questionnaires * Smoking cessation program * Cardiovascular primary prevention * measurement of carbon monoxide (CO) * Blood storage * Computed tomography (CT) scan low-dose

Treatment:

Procedure: Blood sampling

Other: Spirometry

Other: Cardiovascular primary prevention

Other: Smoking cessation program

Diagnostic Test: Computed tomography (CT) scan low dose

Other: Carbon monoxide measurment

Other: Questionnaires

Previous positive high-risk screening subjects

Experimental group

Description:

Subjects enrolled in previous screening cohorts in this Institute with the presence of lung nodules \>4 mm. Additional procedure for this group: Computed tomography (CT) scan low-dose

Treatment:

Other: Smoking cessation program

Diagnostic Test: Computed tomography (CT) scan low dose

Previous negative high-risk screening subjects

No Intervention group

Description:

Subjects enrolled in previous screening cohorts in this Institute with negative computed tomography (CT) scan. No additional procedures for this group.

Lung cancer patients

Experimental group

Description:

Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital. Additional procedures for this group: biobank tissue and blood storage.

Treatment:

Procedure: Tissue sampling (lung)

Procedure: Blood sampling