Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computed tomography (CT) scan low dose, Blood sampling, Tissue sampling (lung), Spirometry.
- Who it may be relevant to
- Registry conditions: Lung Cancer Screening Program, Artificial Intelligence (AI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases
Overview
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.
Interventions
- 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
Primary outcome measures
- Creation of Artificial Intelligence (AI) algorithm [Time frame: from enrollment to 48 months]
Secondary outcome measures (1)
- Multimodal program [Time frame: from enrollment to 48 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Italy · 1 center
- Scientific Institute Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06626178 · CET 288-2024