Precision lung cancer screening using AI risk scores and blood biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, multi-cohort implementation study applying the Sybil AI lung cancer risk model to people undergoing low-dose CT screening. The study enrolls two interventional cohorts that include participants who meet standard USPSTF criteria and those who meet expanded Potter or ACS eligibility. Participants will view a brief educational video about Sybil, provide consent, and some will optionally give blood samples for immunometabolic biomarker analysis. Investigators will measure feasibility, patient comprehension and acceptability, and examine whether integrating blood biomarkers with Sybil and the Brock model improves risk stratification.

Why it matters

Who can join: the full rules

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.

Where it's running

• UI Health
  Chicago, Illinois, United States Recruiting
• UI Health 55th and Pulaski Health Collaborative
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Mary Pasquinelli, DNP — University of Illinois Chicago
• Study coordinator: Mary Pasquinelli, DNP
• Email: Mpasqu3@uic.edu
• Phone: (312) 996-8039

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Methylation markers from saliva to guide lung cancer screening

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• Multilevel program to increase LDCT lung cancer screening and help African American smokers quit

  This program will try combining low-dose CT screening with culturally tailored smoking-cessation support to help African American smokers who are eligible for LDCT quit and get screened.

  Recruiting at 2 sites Louisiana State University Health Sciences Center in New Orleans · New Orleans, Louisiana and 1 other locations · NCT07576595

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.