Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.
NCT ID: NCT06626178
Last Updated: 2024-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2840 participants
INTERVENTIONAL
2024-10-01
2028-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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High-risk screening subjects
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
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.
Blood sampling
Peripheral venous blood sampling (20 ml)
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
Previous positive high-risk screening subjects
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
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.
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
Previous negative high-risk screening subjects
Subjects enrolled in previous screening cohorts in this Institute with negative computed tomography (CT) scan. No additional procedures for this group.
No interventions assigned to this group
Lung cancer patients
Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital. Additional procedures for this group: biobank tissue and blood storage.
Blood sampling
Peripheral venous blood sampling (20 ml)
Tissue sampling (lung)
sampling of tumor and healthy tissue during surgery
Interventions
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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.
Blood sampling
Peripheral venous blood sampling (20 ml)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
* Signed informed consent
* 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
* 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
\- None
Previous high-risk negative screening subjects
\- None
Lung Cancer patients
* computed tomography (CT) scans not available at San Raffaele Hospital
* Previous neoadjuvant treatment
18 Years
ALL
Yes
Sponsors
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Scientific Institute San Raffaele
OTHER
Responsible Party
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Muriana Piergiorgio
Medical Doctor
Locations
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Scientific Institute Ospedale San Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CET 288-2024
Identifier Type: -
Identifier Source: org_study_id
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