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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
United States
Illinois
UI Health 55th and Pulaski Health Collaborative
RECRUITING
Chicago
University of Illinois Cancer Center
RECRUITING
Chicago
Contact Information
Primary
Mary Pasquinelli, DNP
Mpasqu3@uic.edu
(312) 996-8039
Time Frame
Start Date: 2026-03-12
Estimated Completion Date: 2038-02
Participants
Target number of participants: 2500
Treatments
Other: Cohort 1
Participants of this arm meet the United States Preventative Service Task Force (USPSTF) criteria for lung cancer screening. Participants in this cohort will receive a low-dose CT scan as part of their lung cancer screening. They will also view the Sybil AI video, complete surveys, and review their Sybil AI lung cancer risk score. If they agree to participate, they will give optional blood samples.
Other: Cohort 2
Participants of this arm do not meet the United States Preventative Service Task Force (USPSTF) criteria for lung cancer screening but are eligible for lung cancer screening by the Potter or American Cancer Society (ACS) expanded criteria. Participants in this cohort will receive a low-dose CT scan for research purposes. They will also view the Sybil AI video, complete surveys, and review their Sybil AI lung cancer risk score. If they agree to participate, they will give optional blood samples.
No_intervention: Cohort 3
Participants in this arm will be a part of the observational group. Members of this group meet the United States Preventative Service Task Force (USPSTF) criteria. There will be no Sybil score disclosure and demographics will be collected.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov