NCT07458425 · University of Illinois at Chicago
The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk
What this study is about
This is a two-group of participants (screen naïve vs screen established), forward-looking, 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.
View original scientific description
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.
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.
Primary outcome measures
Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR)
Time frame: Day 1 through 30 days post-return of results survey, or approximately Day 60
To evaluate participant reported outcomes before and after return of results (ROR) using the PROMIS test surveys
Multidimensional Impact of Cancer Risk Assessment (MICRA) following return of results (ROR)
Time frame: Day 1 through 30 days post-return of results survey, or approximately Day 60
To evaluate participants' MICRA score following the return of results (ROR)
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)
Time frame: Day 1 through 30 days post-return of results survey, or approximately Day 60
To evaluate the perceptions and health beliefs of participants related to lung cancer screening
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Prior/Concurrent Concomitant Therapy (Medications/Treatments): Definitive treatment for invasive solid tumor or hematologic malignancy within the 5 years prior to the expected enrollment date. Adjuvant hormone therapy for cancer (e.g., for breast or prostate cancer) is not an exclusion criterion.
- 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)
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2026 · Source of record for eligibility and locations