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NCT06320184Active, not recruiting

AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs

Artificial Intelligence Tools Integrating Blood Biomarkers and Radiomics to Define Lung Cancer Risk in Computed Tomography Screening Programs

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

Low-dose computed tomography (LDCT) lung cancer (LC) screening can reduce mortality among heavy smokers, but there is a critical need to better identify people at higher risk and to reduce harms related to management of benign nodules. The most promising strategy is to combine novel tools to optimize clinical decisions and increase the benefit of screening. In this respect, the investigators already demonstrated that the combination of baseline LDCT features with a minimal invasive microRNA blood test was able to more precisely estimate the individual risk of developing LC. The investigators posit that additional immune-related and radiologic features can be integrated with the help of artificial intelligence (AI) to further implement LDCT screening strategies. The project will answer whether the combination of (bio)markers of different origin can predict LC development at baseline and over time, indicate which screen-detected lung nodules are likely to be malignant and ultimately reduce LC and all cause mortality.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
650 (actual)
First submitted
13 Mar 2024
Start date
30 Apr 2023
Primary completion date
30 Oct 2024
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Diseases
Lung cancer
NCT number
NCT06320184

What you commit to

  • Study type: Observational
  • Participants enrolled: 650
  • From 30 Apr 2023 to the primary completion date, 30 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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Who the study is looking for

  • current heavy smokers of ≥ 30 pack/years or former smokers with the same smoking habits having stopped from 10 years or less;
  • current heavy smokers of ≥ 20 pack/years or former smokers with the same smoking habits having stopped from 10 years or less with additional risk factors such as family history of lung cancer, prior diagnosis of chronic obstructive pulmonary disease (COPD) or pneumonia;
  • Suspected solid and sub-solid LDCT lung nodules.

Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.