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AI blood test could spot lung cancer years earlier

NCT ID NCT07458425

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study is testing whether an artificial intelligence (AI) blood test and risk model can help find lung cancer early in people at high risk. Researchers will enroll 400 adults aged 50-80 who smoke or recently quit. Some will get the AI blood test, others an AI analysis of their CT scan. The goal is to see if these tools encourage more people to get screened and improve early detection.

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 (AI) blood test and risk model
What this could lead to
If successful, this could make lung cancer screening easier and more accurate, catching cancers earlier when they are more treatable.
What could go wrong
This is an early study with only 400 people at one center. The AI tool is still research-use-only for some participants, and it may not improve screening rates or detect cancers reliably.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2029

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.

Ages

50 to 80 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: * Participants must be 50-80 years of age, inclusive, at the time of signing the Informed Consent Form (ICF). * Participants must be eligible for LDCT screening as defined by the USPSTF * USPSTF-eligible patients at UI Health and Mile Square FQHC, including primary care and substance use disorder clinics. * Adults who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. * Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. Consent provided by a legally authorized representative is not permitted in this protocol. * Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. * Ability of the subject to understand and comply with study procedures for the entire length of the study. Exclusion Criteria: * Adults who have more than 20 pack-years history but who have not smoked for 15 years or more prior to informed consent (i.e., quit smoking for 15 or more years). * Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality). * Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 5 years prior to the expected enrollment date, or diagnosed greater than 5 years prior to the expected enrollment date and never treated. Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded. * Prior/Concurrent Concomitant Therapy (Medications/Treatments): Definitive treatment for invasive solid tumor or hematologic malignancy within the 5 years prior to the expected enrollment date. Adjuvant hormone therapy for cancer (e.g., for breast or prostate cancer) is not an exclusion criterion. * Individuals who will not be able to comply with the protocol procedures. * Individuals who are not currently registered patients at UIH * Current pregnancy (by self-report of pregnancy status)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

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