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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07458425
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Artificial Intelligence (AI) test — DIAGNOSTIC_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
  • Research-use-only multimodal AI risk model — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Other: Screen-established cohort
    Screen-established participants are individuals who are currently undergoing or have previously undergone LDCT screening. These participants will receive a research-use-only (RUO) multimodal artificial intelligence risk prediction based on lung screening CT imaging and clinical features.
  • Other: Screen-naïve cohort
    In this study, screen-naïve participants are individuals who are eligible for lung cancer screening but have never previously undergone low-dose CT (LDCT) screening. These participants will receive a regulatory cleared laboratory developed test for lung cancer screening, circulating DNA fragmentomics.

Primary Outcome Measure

Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR) [ Time Frame: Day 1 through 30 days post-return of results survey, or approximately Day 60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612-

Find similar trials in Chicago, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Illinois at Chicago· Chicago, IL

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