Systemwide Early Notification Tool for ImmineNt Lung Cancer-1 Study: Evaluating Patient-Reported Outcomes of Artificial Intelligence Inferred Lung Cancer Risk
Trial ID: NCT07458425
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-03-11
Completion date: 2029-01
Sponsor: University of Illinois at Chicago
Conditions: Lung Cancer
Interventions: Artificial Intelligence (AI) test; Research-use-only multimodal AI risk model
Locations: University of Illinois at Chicago
Countries: United States
Enrollment: 400
Age range: 50 Years - 80 Years
Sex: ALL

Summary:
This is a two-cohort (screen naïve vs screen established), prospective, longitudinal, single-center clinical study design that will provide data to comprehensively evaluate patient-reported outcomes of Artificial Intelligence (AI) based prediction of an individual's risk of developing lung cancer over the next 3 years.

Eligibility criteria:
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)

Outcomes:
Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR); Multidimensional Impact of Cancer Risk Assessment (MICRA) following return of results (ROR); Perceptions and health beliefs relating to lung cancer screening using the Lung Health Belief Scale (Lung-HBS) perceived risk and perceived benefits after the return of results (ROR)