LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)
Recruiting · NCT07408531 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
Sybil Artificial Intelligence (AI) screening
What this trial is about
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.
Who can take part
Age range
50 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 50-80 years at the time of consent
- Meets at least one of the following LCS eligibility criteria:
- USPSTF: ≥20 pack-years, currently smoke or quit ≤15 years ago.
- Potter: 20 years of smoking, regardless of intensity
- ACS: ≥20 pack-years, no restriction on quit time
- Receiving or scheduled for LDCT through the UI Health Lung Screening Program.
- Willing to view a short (approximately 2-minute) educational video that explains Sybil AI scoring and LCS, complete the Sybil AI survey (if selected), and/or provide blood samples (optional).
- Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC IRB ICF and HIPAA authorization.
- Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
Exclusion criteria
- Inability to undergo LDCT
- Current diagnosis or history of lung cancer \< 5 years prior to study enrollment.
- Life expectancy \<1 year
- Active lung infection requiring systemic therapy
- Vulnerable population, including prisoners and pregnant or nursing women, will not be enrolled due to radiation exposure from LDCT, which is contraindicated in pregnancy.
- Other major comorbidity, as determined by the study PI
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
Where it is running
2 locations listed across 1 US state.
- UI Health - Chicago, Illinois, United States
- UI Health 55th and Pulaski Health Collaborative - Chicago, Illinois, United States