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RECRUITING

NCT07458425

The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk

Sponsor: University of Illinois at Chicago

View on ClinicalTrials.gov

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.

Official title: Systemwide Early Notification Tool for ImmineNt Lung Cancer-1 Study: Evaluating Patient-Reported Outcomes of Artificial Intelligence Inferred Lung Cancer Risk

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-03-11

Completion Date

2029-01

Last Updated

2026-04-06

Healthy Volunteers

Yes

Conditions

Lung Cancer

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence (AI) test

Individuals eligible for lung cancer screening by the USPSTF who have never undergone lung cancer screening with low-dose CT will receive a regulatory cleared laboratory developed blood test for lung cancer screening, circulating DNA fragmentomics

DIAGNOSTIC_TEST

Research-use-only multimodal AI risk model

For USPSTF-eligible individuals who have already received low-dose CT screening, these individuals will receive a research-use-only (RUO) multimodal artificial intelligence risk prediction based on lung screening CT imaging and clinical features.

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)

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States