Clinical trial · Interventional
Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.
ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases
NCT06626178CI-TRIAL-00081269ARIArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence (AI) | — | UNRESOLVED | — |
| Lung Cancer Screening Program | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
| Carbon monoxide measurment | Other | — | UNRESOLVED |
| Cardiovascular primary prevention | Other | — | UNRESOLVED |
| Computed tomography (CT) scan low dose | Diagnostic Test | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Smoking cessation program | Other | — | UNRESOLVED |
| Spirometry | Other | — | UNRESOLVED |
| Tissue sampling (lung) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- High-risk screening subjects
- description
- 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
- interventionNames
- Diagnostic Test: Computed tomography (CT) scan low dose
- Procedure: Blood sampling
- Other: Spirometry
- Other: Questionnaires
- Other: Smoking cessation program
- Other: Carbon monoxide measurment
- Other: Cardiovascular primary prevention
- type
- EXPERIMENTAL
- label
- Previous positive high-risk screening subjects
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.