LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07408531
Status
Recruiting

Conditions

  • Lung Cancer Screening

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Sybil Artificial Intelligence (AI) screening — DIAGNOSTIC_TEST
    Low-dose CT scans will be analyzed using the Sybil Artificial Intelligence (AI) screening tool

Study Details

This research study aims to investigate methods for enhancing lung cancer screening. The study will investigate whether an artificial intelligence (AI) tool, known as Sybil, can aid in predicting the risk of lung cancer. The investigators will also examine whether expanding the screening criteria (based on the guidelines of the Potter and American Cancer Society (ACS)) can help identify individuals at risk who are not currently included in the U.S. Preventive Services Task Force (USPSTF) guidelines.

Key Dates

Start date
Mar 12, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2038

Study Design

Enrollment
2,500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Other: Cohort 1
    Participants of this arm meet the United States Preventative Service Task Force (USPSTF) criteria for lung cancer screening. Participants in this cohort will receive a low-dose CT scan as part of their lung cancer screening. They will also view the Sybil AI video, complete surveys, and review their Sybil AI lung cancer risk score. If they agree to participate, they will give optional blood samples.
  • Other: Cohort 2
    Participants of this arm do not meet the United States Preventative Service Task Force (USPSTF) criteria for lung cancer screening but are eligible for lung cancer screening by the Potter or American Cancer Society (ACS) expanded criteria. Participants in this cohort will receive a low-dose CT scan for research purposes. They will also view the Sybil AI video, complete surveys, and review their Sybil AI lung cancer risk score. If they agree to participate, they will give optional blood samples.
  • No Intervention: Cohort 3
    Participants in this arm will be a part of the observational group. Members of this group meet the United States Preventative Service Task Force (USPSTF) criteria. There will be no Sybil score disclosure and demographics will be collected.

Primary Outcome Measure

Expanded screening eligibility with Sybil AI risk scoring [ Time Frame: Up to 10 years post-study entry ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UI Health 55th and Pulaski Health CollaborativeChicagoIllinois60629
Mary Pasquinelli, DNP
312-996-8039
University of Illinois Cancer CenterChicagoIllinois60612
Mary Pasquinelli, DNP
312-996-8039

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