Using AI to identify and prevent smoking-related diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional pilot study aims to develop and validate an artificial intelligence model that can accurately detect lung nodules and differentiate between malignant and benign tumors in high-risk individuals. The study involves a single-center approach at the Scientific Institute Ospedale San Raffaele in Milan, where participants will undergo low-dose CT scans, blood sampling, spirometry, and complete various questionnaires. The target population includes smokers and former smokers over 50 years old who are at high risk for lung cancer, as well as those enrolled in previous screening cohorts.

Why it matters

Who can join: the full rules

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

Where it's running

• Scientific Institute Ospedale San Raffaele
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Piergiorgio Muriana, MD
• Email: muriana.piergiorgio@hsr.it
• Phone: 0226437232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.