AI blood test could spot lung cancer years earlier
NCT ID NCT07458425
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
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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
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Illinois at Chicago
RECRUITINGChicago, Illinois, 60612, United States
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