Trial Title:
Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.
NCT ID:
NCT06626178
Condition:
Lung Cancer Screening Program
Artificial Intelligence (AI)
Conditions: Official terms:
Lung Neoplasms
Carbon Monoxide
Conditions: Keywords:
CT scan low-dose
Artificial Intelligence
High-risk sucjects
Lung cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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).
Primary purpose:
Screening
Masking:
None (Open Label)
Masking description:
No blinding in this study
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Computed tomography (CT) scan low dose
Description:
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.
Arm group label:
High-risk screening subjects
Arm group label:
Previous positive high-risk screening subjects
Intervention type:
Procedure
Intervention name:
Blood sampling
Description:
Peripheral venous blood sampling (20 ml)
Arm group label:
High-risk screening subjects
Arm group label:
Lung cancer patients
Intervention type:
Procedure
Intervention name:
Tissue sampling (lung)
Description:
sampling of tumor and healthy tissue during surgery
Arm group label:
Lung cancer patients
Intervention type:
Other
Intervention name:
Spirometry
Description:
Spirometry measurement using spirometer
Arm group label:
High-risk screening subjects
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Compilation of epidemiological questionnaire, quality of life questionnaires
Arm group label:
High-risk screening subjects
Intervention type:
Other
Intervention name:
Smoking cessation program
Description:
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
Arm group label:
High-risk screening subjects
Arm group label:
Previous positive high-risk screening subjects
Intervention type:
Other
Intervention name:
Carbon monoxide measurment
Description:
Measurment of Carbon monoxide (CO)
Arm group label:
High-risk screening subjects
Intervention type:
Other
Intervention name:
Cardiovascular primary prevention
Description:
Intervention done in order to find the presence of coronary calcifications
Arm group label:
High-risk screening subjects
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Scientific Institute Ospedale San Raffaele
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Piergiorgio Muriana, MD
Phone:
0226437232
Phone ext:
+39
Email:
muriana.piergiorgio@hsr.it
Investigator:
Last name:
Piergiorgio Muriana, MD
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
November 1, 2028
Lead sponsor:
Agency:
Scientific Institute San Raffaele
Agency class:
Other
Source:
Scientific Institute San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06626178
