Actively Recruiting
LUNG-07: Advancing Precision-Based Lung Cancer Screening with AI-Guided Risk Stratification and Biomarker Integration
Led by University of Illinois at Chicago · Updated on 2026-04-13
2500
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve lung cancer screening by studying an artificial intelligence (AI) tool called Sybil. This tool aims to predict the risk of lung cancer more accurately. The study also examines whether expanding screening eligibility based on Potter and American Cancer Society (ACS) guidelines can better identify individuals at risk who are not currently included under the U.S. Preventive Services Task Force (USPSTF) guidelines. The study involves participants who are either eligible under USPSTF guidelines or under expanded criteria from Potter and ACS. Participants in the interventional groups will receive low-dose CT scans for lung cancer screening, watch an educational video about Sybil AI, complete surveys, and review their AI risk scores. Some may also provide optional blood samples to study biomarkers. There is also an observational group meeting USPSTF criteria who will have demographic data collected but no Sybil AI score disclosure. Participants will be involved in surveys and educational activities, with some providing blood samples for biomarker research. Researchers will assess participant understanding and acceptance of Sybil AI risk scores, analyze AI performance across different eligibility groups, and develop a lung cancer biorepository. Outcomes include long-term follow-up of AI risk scoring and combined biomarker models for up to 10 years after study entry.
CONDITIONS
Brief Title
LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 80 years at the time of consent
- Meet at least one lung cancer screening eligibility: USPSTF (20+ pack-years, current smoker or quit within 15 years), Potter (20 years smoking regardless of intensity), or ACS (20+ pack-years, no quit time restriction)
- Receiving or scheduled for low-dose CT through the UI Health Lung Screening Program
- Willing to watch a short educational video about Sybil AI and lung screening, complete surveys, and optionally provide blood samples
- Able to provide written informed consent and HIPAA authorization
- Women of childbearing potential must not be pregnant or breastfeeding and require a negative pregnancy test
- Able to understand and comply with study procedures as determined by the enrolling physician
You will not qualify if you...
- Unable to undergo low-dose CT scan
- Current lung cancer diagnosis or history within 5 years before enrollment
- Life expectancy less than 1 year
- Active lung infection requiring systemic therapy
- Vulnerable populations like prisoners and pregnant or nursing women
- Other major health conditions as determined by the study investigator
- Any mental or medical condition that prevents informed consent or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years post-study entry
Participants undergo low-dose CT lung cancer screening with AI-guided risk stratification and optionally provide blood samples for biomarker analysis. They watch an educational video and complete surveys about the AI risk scores.
Visits occur as part of routine lung cancer screening and study assessments; timing may vary depending on cohort assignment
Trial Site Locations
Total: 2 locations
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
UI Health 55th and Pulaski Health Collaborative
Chicago, Illinois, United States, 60629
Actively Recruiting
Research Team
M
Mary Pasquinelli, DNP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here