Artificial Intelligence in Lung Cancer Screening

NCT06444373 | Completed

• 1 other identifier: 116/INT/2022
• Study Type: observational
• Target: 728
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.

Conditions

Lung Cancer Screening; Asbestos

Keywords

Artificial Intelligence; Asbestos; Lung Cancer Screening

Outcome Measures

Primary Outcomes (1)

• AIM 1 Pilot deep learning model

  Development and fine-tuning of a pilot deep learning model for automatic detection and diagnosis of screen-detected nodules for risk stratification in subjects with asbestos exposure as part of a lung cancer screening program in high-risk subjects for exposure to asbestos and smoking on retrospective data.

  from enrollment to the end of treatment at 2 years

Secondary Outcomes (1)

• AIM 2 Clinical database

  from enrollment to the end of treatment at 2 years

Study Arms (1)

subjects enrolled in lung cancer screening

Actual Smokers or formers smoker; Age \> 50 years.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age \> 50 years; smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos. All subjects were enrolled in lung cancer screening program.

You may qualify if:

• Age \> 50 years;
• smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;
• and/or previous professional exposure to asbestos;
• absence of lung cancer symptoms;
• who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee

You may not qualify if:

• Age \< 50 years
• never smokers
• lung cancer symptoms

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: December 2, 2022
• Primary Completion: May 22, 2024
• Study Completion: May 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

IT (1)