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AI + blood test could spot lung cancer earlier in smokers

NCT ID NCT06320184

Knowledge-focused Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether combining artificial intelligence with blood biomarkers and CT scan features can better predict lung cancer risk in heavy smokers. Researchers will analyze data from 650 participants to develop a risk model that improves screening accuracy and reduces unnecessary follow-ups. The goal is to make lung cancer screening more precise and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Artificial intelligence risk model combining blood biomarkers, radiologic parameters, and clinical features
What this could lead to
If successful, this could lead to a more accurate, non-invasive way to identify who is at high risk for lung cancer, reducing unnecessary procedures and catching cancers earlier.
What could go wrong
This is an observational study, not a treatment trial. The AI model may not perform as well in real-world settings, and results may take years to validate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

650 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

LDCT screening volunteers enrolled in the BioMILD trial (clinicaltrial.gov NCT02247453) with solid and sub-solid baseline LDCT lung nodules, including baseline-identified cancer patients, in the SMILE trial (clinicaltrial.gov NCT03654105) and in the RISP trial (clinicaltrial.gov NCT05766046).

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood biomarkers Lung cancer

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.