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The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk screening subjects | Experimental | 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:
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| Previous positive high-risk screening subjects | Experimental | 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 |
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| Previous negative high-risk screening subjects | No Intervention | 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 | Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital. Additional procedures for this group: biobank tissue and blood storage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomography (CT) scan low dose | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of Artificial Intelligence (AI) algorithm | To train and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types. AUC (Area Under the Curve) values, expressed as mean and standard deviation (SD), comparing the ability in detecting the presence of nodules and differentiating the malignancy or benignity of a radiologist versus an AI algorithm, both trained on the same patient group. | from enrollment to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Multimodal program | Develop a multimodal program to enhance the prevention and the early detection of multiple smoking-related diseases Presence and absence of lung nodules > 4 mm with computed tomography (CT) scan | from enrollment to 48 months |
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High-risk screening subjects
Inclusion Criteria:
Exclusion Criteria:
Previous high-risk positive screening subjects
Inclusion Criteria:
Exclusion Criteria:
- None
Previous high-risk negative screening subjects
Inclusion Criteria:
Exclusion Criteria:
- None
Lung Cancer patients
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piergiorgio Muriana, MD | Contact | 0226437232 | +39 | muriana.piergiorgio@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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In the study are considered 4 different cohorts. Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital; smokers and former smokers aged over 50 years old at high risk for lung cancer, cardiovascular diseases and chronic obstructive pulmonary disease (COPD); subjects enrolled in previous screening cohorts in this Institute, which presented a computed tomography (CT) with the presence of lung nodules >4 mm and to conclude, subjects enrolled in previous screening cohorts in this Institute, which presented a negative computed tomography (CT).
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No blinding in this study
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| Blood sampling | Procedure | Peripheral venous blood sampling (20 ml) |
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| Tissue sampling (lung) | Procedure | sampling of tumor and healthy tissue during surgery |
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| Spirometry | Other | Spirometry measurement using spirometer |
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| Questionnaires | Other | Compilation of epidemiological questionnaire, quality of life questionnaires |
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| Smoking cessation program | Other | 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 |
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| Carbon monoxide measurment | Other | Measurment of Carbon monoxide (CO) |
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| Cardiovascular primary prevention | Other | Intervention done in order to find the presence of coronary calcifications |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D011877 | Radionuclide Imaging |
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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