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

August 3, 2026 updated by: Mary Pasquinelli, DNP, APRN, University of Illinois at Chicago
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, non-randomized, multi-cohort implementation study designed to evaluate the feasibility, acceptability, and outcomes of Sybil AI, an AI-based lung cancer risk prediction model, in both guideline-eligible and expanded-eligibility populations undergoing low-dose CT (LDCT) lung cancer screening (LCS). The study includes two interventional cohorts (Cohorts 1 & 2). Aim 1 of the study is to prospectively apply Sybil AI risk scores to a cohort that meets the USPSTF lung screening criteria and the expanded eligibility (Potter & ACS) and evaluate patient comprehension and acceptability. Aim 2 of the study is to collect and analyze blood-based biospecimens to identify immunometabolic biomarkers and assess their integration with Sybil AI and the Brock model for improved risk stratification.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mary Pasquinelli, DNP
  • Phone Number: (312) 996-8039
  • Email: Mpasqu3@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • UI Health
        • Contact:
      • Chicago, Illinois, United States, 60629
        • Recruiting
        • UI Health 55th and Pulaski Health Collaborative
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 and complete surveys. If they agree to participate, they will give optional blood samples.
Diagnostic test: Sybil Artificial Intelligence (AI) screening
Low-dose CT scans will be analyzed using the Sybil Artificial Intelligence (AI) screening tool
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 and complete surveys. If they agree to participate, they will give optional blood samples.
Diagnostic test: Sybil Artificial Intelligence (AI) screening
Low-dose CT scans will be analyzed using the Sybil Artificial Intelligence (AI) screening tool

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 10 years post-study entry
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.
Up to 10 years post-study entry
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.
Up to 10 years post-study entry

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sybil AI performance across eligibility cohorts
Time Frame: Up to 10 years post-study entry
To evaluate Sybil AI lung cancer risk prediction performance stratified by eligibility cohort (USPSTF vs expanded criteria), assessed by AUC, sensitivity, specificity, and calibration
Up to 10 years post-study entry
Participant comprehension and acceptability of Sybil AI risk scores
Time Frame: Up to 10 years post-study entry
To evaluate participant-reported comprehension, trust, and acceptability of Sybil AI risk scores measured using standardized survey instruments and summarized as scale scores and proportions
Up to 10 years post-study entry
Clinical outcomes across eligibility groups
Time Frame: Up to 10 years post-study entry
To evaluate lung cancer detection rate, stage at diagnosis, and low-dose CT appointment no-show rates compared across eligibility groups using clinical and imaging records
Up to 10 years post-study entry
Lung cancer biorepository development
Time Frame: Up to 10 years post-study entry
To evaluate number and characteristics of biospecimens collected, including biospecimen type, participant demographics, eligibility group, and linkage to clinical and imaging data
Up to 10 years post-study entry

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluating blood-based immunometabolic biomarker levels
Time Frame: Up to 10 years post-study entry
To evaluate blood-based immunometabolic biomarker levels measured and analyzed in relation to Sybil AI lung cancer risk scores and confirmed lung cancer diagnoses
Up to 10 years post-study entry
Evaluating predictive performance
Time Frame: Up to 10 years post-study entry
To evaluate predictive performance of models incorporating immunometabolic biomarkers and the Brock model assessed using discrimination metrics including AUC and risk reclassification
Up to 10 years post-study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary Pasquinelli, DNP, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-0996

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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