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

NCT07458425 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-06

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence (AI) 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

DIAGNOSTIC_TEST

Research-use-only multimodal AI risk model

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.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Ameen Salahudeen, MD, PhD · University of Illinois at Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2027-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07458425 on ClinicalTrials.gov