Systemwide Early Notification Tool for ImmineNt Lung Cancer-1 Study: Evaluating Patient-Reported Outcomes of Artificial Intelligence Inferred Lung Cancer Risk
AI tool predicts lung cancer risk, studies patient outcomes
Plain English Summary
The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk is a Not Applicable clinical trial sponsored by University of Illinois at Chicago studying Lung Cancer. This study tests an AI tool that predicts your risk of developing lung cancer in the next 3 years. It is for adults aged 50-80 who are eligible for lung cancer screening and have a history of smoking. Participation involves taking a blood test and/or an AI risk assessment based on imaging, and completing surveys about your experience. Alternatives include standard lung cancer screening guidelines based on age and smoking history. The trial aims to enroll 400 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 80 years old and eligible for lung cancer screening based on your smoking history (at least 20 pack-years) and quitting within the last 15 years. You cannot join if you quit smoking more than 15 years ago, are currently being evaluated for cancer, have had certain cancers treated in the last 5 years, or are pregnant or breastfeeding. You must be a registered patient at UI Health or Mile Square FQHC and able to give informed consent. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure how patients feel and what they believe about their lung cancer risk after using the AI prediction tool, helping to understand the impact of this new technology on patient well- The specific primary outcome measures are: Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR) (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) (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) (Day 1 through 30 days post-return of results survey, or approximately Day 60). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores how an AI tool can help identify individuals at high risk for lung cancer early, potentially filling a gap in proactive cancer detection. This research targets Lung Cancer, where improved treatment options are needed.
Investor Insight
This study signals a growing investment in AI for early disease detection, particularly in oncology, with potential to improve screening efficiency and patient outcomes in a large market.
Is This Trial Right for Me?
Ask your doctor if you are eligible for lung cancer screening and how this AI tool might fit into your care. Participation involves regular check-ins, surveys, and potentially a blood test or imaging scan. The study aims to understand your experience and feelings about the AI-generated risk assessment. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 400 participants
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 Outcomes
- Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR) (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) (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) (Day 1 through 30 days post-return of results survey, or approximately Day 60)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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)
Trial Locations
- University of Illinois at Chicago, Chicago, Illinois, United States
Frequently Asked Questions
What is clinical trial NCT07458425?
NCT07458425 is a Not Applicable INTERVENTIONAL study titled "The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk." It is currently recruiting and is sponsored by University of Illinois at Chicago. The trial targets enrollment of 400 participants.
What conditions does NCT07458425 study?
This trial investigates treatments for Lung Cancer. The primary condition under study is Lung Cancer.
What treatments are being tested in NCT07458425?
The interventions being studied include: Artificial Intelligence (AI) test (DIAGNOSTIC_TEST), Research-use-only multimodal AI risk model (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
What does Not Applicable mean for NCT07458425?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07458425?
This trial is currently "Recruiting." It started on 2026-03-11. The estimated completion date is 2029-01.
Who is sponsoring NCT07458425?
NCT07458425 is sponsored by University of Illinois at Chicago. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07458425?
The trial aims to enroll 400 participants. The trial is currently recruiting and accepting new participants.
How is NCT07458425 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07458425?
The primary outcome measures are: Patient Reported Outcomes Measurement Information System (PROMIS) survey results before and following the return of results (ROR) (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) (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) (Day 1 through 30 days post-return of results survey, or approximately Day 60). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07458425 being conducted?
This trial is being conducted at 1 site, including Chicago, Illinois (United States).
Where can I find official information about NCT07458425?
The official record for NCT07458425 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07458425. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07458425 testing in simple terms?
This study tests an AI tool that predicts your risk of developing lung cancer in the next 3 years. It is for adults aged 50-80 who are eligible for lung cancer screening and have a history of smoking.
Why is this trial significant?
This trial matters because it explores how an AI tool can help identify individuals at high risk for lung cancer early, potentially filling a gap in proactive cancer detection.
What are the potential risks of participating in NCT07458425?
Potential risks include anxiety or distress from receiving a high-risk prediction. Side effects are generally related to the diagnostic tests, such as minor discomfort from a blood draw or radiation exposure from CT scans (if applicable). There's a possibility of false positive or false negative results from the AI prediction. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07458425?
Ask your doctor if you are eligible for lung cancer screening and how this AI tool might fit into your care. Participation involves regular check-ins, surveys, and potentially a blood test or imaging scan. The study aims to understand your experience and feelings about the AI-generated risk assessment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07458425 signal from an investment perspective?
This study signals a growing investment in AI for early disease detection, particularly in oncology, with potential to improve screening efficiency and patient outcomes in a large market. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves taking a blood test and/or an AI risk assessment based on imaging, and completing surveys about your experience. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.