NCT07408531 · University of Illinois at Chicago
LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)
What this study 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Sybil Artificial Intelligence (AI) screening
Low-dose CT scans will be analyzed using the Sybil Artificial Intelligence (AI) screening tool
Primary outcome measures
Expanded screening eligibility with Sybil AI risk scoring
Time frame: Up to 10 years post-study entry
To assess eligibility classification using USPSTF versus expanded criteria (Potter and American Cancer Society) and Sybil AI lung cancer risk scores calculated for all participants, including overlap between eligibility groups.
Sybil AI performance in USPSTF-eligible participants
Time frame: Up to 10 years post-study entry
To evaluate Sybil AI lung cancer risk prediction performance among USPSTF-eligible participants, assessed by discrimination and calibration metrics including AUC, sensitivity, specificity, and observed lung cancer incidence.
Combined biomarker, Sybil AI, and Brock model risk stratification
Time frame: Up to 10 years post-study entry
To assess risk stratification performance of integrated models incorporating immunometabolic biomarkers, Sybil AI risk scores, and the Brock model, assessed by AUC and risk reclassification measures.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations