Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.
Recruiting · NCT06626178 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Blood samplingCarbon monoxide measurmentCardiovascular primary preventionComputed tomography (CT) scan low doseQuestionnairesSmoking cessation programSpirometryTissue sampling (lung)
What this trial is about
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Scientific Institute Ospedale San Raffaele - Milan, Italy