The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk

NCT07458425 | Not Yet Recruiting DMC

• 1 other identifier: 2025-0860
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Lung cancer screening

Outcome Measures

Primary Outcomes (3)

• Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR)

  To evaluate participant reported outcomes before and after return of results (ROR) using the PROMIS test surveys

  Day 1 through 30 days post-return of results survey, or approximately Day 60

• Multidimensional Impact of Cancer Risk Assessment (MICRA) following return of results (ROR)

  To evaluate participants' MICRA score following the return of results (ROR)

  Day 1 through 30 days post-return of results survey, or approximately Day 60

• Perceptions and health beliefs relating to lung cancer screening using the Lung Health Belief Scale (Lung-HBS) perceived risk and perceived benefits after the return of results (ROR)

  To evaluate the perceptions and health beliefs of participants related to lung cancer screening

  Day 1 through 30 days post-return of results survey, or approximately Day 60

Secondary Outcomes (1)

• Rates of participant adherence to LDCT and smoking cessation within one year of return of results (ROR).

  Screening through 1 year post-return of results

Study Arms (2)

Screen-established cohort

OTHER

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.

Diagnostic Test: Research-use-only multimodal AI risk model

Screen-naïve cohort

OTHER

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.

Diagnostic Test: Artificial Intelligence (AI) test

Interventions

Artificial Intelligence (AI) test DIAGNOSTIC_TEST

Individuals eligible for lung cancer screening by the USPSTF who have never undergone lung cancer screening with low-dose CT will receive a regulatory cleared laboratory developed blood test for lung cancer screening, circulating DNA fragmentomics

Screen-naïve cohort

Research-use-only multimodal AI risk model DIAGNOSTIC_TEST

For USPSTF-eligible individuals who have already received low-dose CT screening, these individuals will receive a research-use-only (RUO) multimodal artificial intelligence risk prediction based on lung screening CT imaging and clinical features.

Screen-established cohort

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 50-80 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
• Participants must be eligible for LDCT screening as defined by the USPSTF
• USPSTF-eligible patients at UI Health and Mile Square FQHC, including primary care and substance use disorder clinics.
• Adults who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.
• 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.
• Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
• Ability of the subject to understand and comply with study procedures for the entire length of the study.

You may not qualify if:

• Adults who have more than 20 pack-years history but who have not smoked for 15 years or more prior to informed consent (i.e., quit smoking for 15 or more years).
• Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
• Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 5 years prior to the expected enrollment date, or diagnosed greater than 5 years prior to the expected enrollment date and never treated. Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
• Individuals who will not be able to comply with the protocol procedures.
• Individuals who are not currently registered patients at UIH
• Current pregnancy (by self-report of pregnancy status)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Study Officials

• Ameen Salahudeen, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameen Salahudeen, MD, PhD

CONTACT

(312) 355-1625; ameen@uic.edu

Erica Seltzer, DrPh, MPH

CONTACT

(312) 413-7432; eseltzer@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03