NCT07408531

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a prospective, non-randomized, multi-cohort implementation study designed to evaluate the feasibility, acceptability, and outcomes of Sybil AI, an AI-based lung cancer risk prediction model, in both guideline-eligible and expanded-eligibility populations undergoing low-dose CT (LDCT) lung cancer screening (LCS). The study includes two interventional cohorts (Cohorts 1 \& 2). Aim 1 of the study is to prospectively apply Sybil AI risk scores to a cohort that meets the USPSTF lung screening criteria and the expanded eligibility (Potter \& ACS) and evaluate patient comprehension and acceptability. Aim 2 of the study is to collect and analyze blood-based biospecimens to identify immunometabolic biomarkers and assess their integration with Sybil AI and the Brock model for improved risk stratification.

Conditions

• Lung Cancer Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sybil Artificial Intelligence (AI) screening	Low-dose CT scans will be analyzed using the Sybil Artificial Intelligence (AI) screening tool

Timeline

• Start date: 2026-03-12
• Primary completion: 2028-02-01
• Completion: 2038-02-01
• First posted: 2026-02-13
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States