NCT07408531Recruiting
LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 12 Mar 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Lung cancer
- NCT number
- NCT07408531
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From 12 Mar 2026 to the primary completion date, Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current diagnosis or history of lung cancer \< 5 years prior to study enrollment.
- 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 illness
- Active lung infection requiring systemic therapy
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
Other
- Inability to undergo LDCT
- Life expectancy \<1 year
- Other major comorbidity, as determined by the study PI
Who the study is looking for
- 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
Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UI Health 55th and Pulaski Health Collaborative Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| UI Health Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.