NCT07517393

Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)

LUCE: LUng Cancer (r)Evolution

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Casa di Cura Dott. Pederzoli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study aims to retrospectively and prospectively analyze the clinical, anamnestic, functional, biological data of patients who have performed or will perform non-contrast chest photon count CT. The use of contrast medium is evaluated by the physician. Main objective The study aims to understand how many people who undergo non-contrast photon-counting chest CT have: lung nodules, chest tumors, and other non-cancerous lung diseases. Secondary objectives * Analyze the data with the help of artificial intelligence to create a "digital twin" of the lung, that is, a virtual copy of the lung that allows you to study and simulate the behavior of the lung for research and analysis purposes, without directly intervening on the patient. * Follow any suspicious lung changes over time to understand how they change and whether they are linked to clinical, biological, or laboratory parameters. The enrollment phase will last 12 months and will begin with the approval of the study. At this stage, clinical data already present in the patient's medical record and data relating to the photon count CT examination will be collected. After the enrollment phase, the patient will be observed for a further total duration of 10 years: in particular, a follow-up visit will be arranged at two, five and ten years. More specifically, if there are no radiological elements that require scheduling a visit to the center, the patient will be contacted by telephone for a telematic update of the data. If, however, pulmonary alterations are identified during the study, the patient will be referred to the Reference Operating Unit, as per clinical practice, to continue with the most appropriate personalized diagnostic-therapeutic process. In these cases, the patient will be contacted by telephone and an appointment with the institution will be suggested.

Conditions

• Thoracic Neoplasm
• Pulmonary Nodules
• Non-oncological Pulmonary Pathologies

Timeline

• Start date: 2026-04-01
• Primary completion: 2036-03-01
• Completion: 2036-03-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Italy