AI Test for Lung Cancer Risk

Overseen By Erica Seltzer, DrPh, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Adjuvant hormone therapy

Disqualifiers: Recent cancer, Smoking cessation, others

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

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a two-cohort (screen naïve vs screen established), prospective, longitudinal, single-center clinical study design that will provide data to comprehensively evaluate patient-reported outcomes of Artificial Intelligence (AI) based prediction of an individual's risk of developing lung cancer over the next 3 years.

Who Is on the Research Team?

Ameen Salahudeen, MD, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able to understand and follow all study instructions.

* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. Consent provided by a legally authorized representative is not permitted in this protocol.

I am not pregnant or breastfeeding and have a recent negative pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

12 months

Multiple visits for recruitment and eligibility assessment

Intervention

Participants receive AI-based lung cancer risk prediction tests and return of results

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for patient-reported outcomes and adherence to LDCT and smoking cessation

1 year post-return of results

Surveys and assessments at multiple intervals

What Are the Treatments Tested in This Trial?

Interventions

• AI-Inferred Lung Cancer Risk Prediction

How Is the Trial Designed?

Group I: Screen-naïve cohort Experimental Treatment 1 Intervention

In this study, screen-naïve participants are individuals who are eligible for lung cancer screening but have never previously undergone low-dose CT (LDCT) screening. These participants will receive a regulatory cleared laboratory developed test for lung cancer screening, circulating DNA fragmentomics.

Group II: Screen-established cohort Experimental Treatment 1 Intervention

Screen-established participants are individuals who are currently undergoing or have previously undergone LDCT screening. These participants will receive a research-use-only (RUO) multimodal artificial intelligence risk prediction based on lung screening CT imaging and clinical features.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+