AI Screening for Lung Cancer

Not yet recruiting at 2 trial locations

Overseen By Mary Pasquinelli, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Lung cancer, Life expectancy <1 year, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Mary Pasquinelli, DNP

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

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)

Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines

I am getting or will get a low-dose CT scan for lung screening at UI Health.

Exclusion Criteria

I was diagnosed with lung cancer less than 5 years ago.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a low-dose CT scan and view the Sybil AI video. They complete surveys and review their Sybil AI lung cancer risk score. Optional blood samples are collected.

Ongoing

1 visit (in-person)

Follow-up

Participants are monitored for lung cancer risk prediction performance and biomarker analysis.

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Sybil Artificial Intelligence (AI) screening

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

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.

Group II: Cohort 1 Experimental Treatment 1 Intervention

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.

Group III: Cohort 3 Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+