Systemwide Early Notification Tool for ImmineNt Lung Cancer-1 Study: Evaluating Patient-Reported Outcomes of Artificial Intelligence Inferred Lung Cancer Risk
University of Illinois at Chicago
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.
Description
This is a prospective, longitudinal, single-center interventional study of AI lung cancer prediction tests with return of results at the University of Illinois Hospital clinics. The purpose is to evaluate patient-reported outcomes of AI risk inference. The motivation for the study was based on findings that existing AI tests have been designed without including patient populations like those at UI Health. Using newer, more generalizable AI tests, UI Health researchers will evaluate patient perceptions of AI risk and how that impacts their beliefs about their health and lung cancer screening.…
Eligibility
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- Yes
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)…
Interventions
- Diagnostic TestArtificial 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 TestResearch-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.
Location
- University of Illinois at ChicagoChicago, Illinois