NCT07458425Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 11 Mar 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Lung cancer
- NCT number
- NCT07458425
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 11 Mar 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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.
Other illness
- 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.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.