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New treatment option for Lung Cancer
Official title The SENTINL-1 Study: Evaluating Patient-Reported Outcomes of AI-Inferred Lung Cancer Risk
ClinicalTrials.gov ID: NCT07458425
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or...
- Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 5 years prior to the expected enrollment date, or diagnosed...
- Prior/Concurrent Concomitant Therapy (Medications/Treatments): Definitive treatment for invasive solid tumor or hematologic malignancy within the 5...
- Individuals who will not be able to comply with the protocol procedures.
- Individuals who are not currently registered patients at UIH
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.