The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk
Systemwide Early Notification Tool for ImmineNt Lung Cancer-1 Study: Evaluating Patient-Reported Outcomes of Artificial Intelligence Inferred Lung Cancer Risk
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at what patients report after AI (artificial intelligence) predicts their risk of lung cancer over the next 3 years. It is for adults ages 50–80 who qualify for lung cancer screening, including people who have and have not been screened before.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 50–80 years old when you sign the consent form.
- Qualify for low-dose CT lung screening under U.S. Preventive Services Task Force guidelines. This scan uses low amounts of radiation.
- Be a patient at UI Health or Mile Square health centers, including primary care and substance use treatment clinics.
- Have smoked at least 20 pack-years and still smoke or have quit within the past 15 years. One pack-year means smoking one pack a day for one year.
- Be able to sign your own consent form and give permission to share your health information. Someone else cannot consent for you.
- If you could become pregnant, you must not be pregnant or breastfeeding and must have a negative pregnancy test.
- Be able to understand and follow study steps for the whole study.
Who can't join
- Have smoked more than 20 pack-years but quit 15 or more years before signing consent.
- Be getting or referred for tests because a doctor suspects cancer, such as a biopsy to take a tissue sample.
- Have had an invasive solid cancer or blood cancer diagnosed in the past 5 years, or an older cancer that was never treated. Basal cell or squamous cell skin cancer that has not spread does not exclude you.
- Have received treatment aimed at treating an invasive solid cancer or blood cancer in the past 5 years. Added hormone therapy for cancer does not exclude you.
- Be unable to follow the study steps.
- Not be a currently registered UI Health patient.
- Be pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
IL
- University of Illinois at Chicago · Chicago, IL 60612More trials in Chicago