An Observational Study of Lung Screening in Individuals at High Risk for Lung Cancer Who Do Not Meet the Uspstf Criteria
Study on Lung Screening in High-Risk Individuals
Julian Marin Acevedo
Primary Investigator
Brief description of study
Study purposse: Describe the demographics, risk factors for lung cancer, and baseline Lung Rads score of individuals enrolled in this observational study. Using descriptive statistics, compare the demographics and Lung Rads score of the participants enrolled in this study with those participating in the NLST and NELSON studies. Using descriptive statistics, compare the demographics and Lung Rads score of the participants enrolled in this study with a cohort of participants in the lung screening program at IU Health
Participants will be recruited by advertisements and at community events. Participants will undergo their lung screening at IU Health fixed lung screening sites or through the IU Health mobile lung screening program.
Detailed description of study
This will be a prospective study of individuals undergoing lung screening who meet eligibility criteria. Eligible participants will complete a one-time survey to document age, sex, and risk factors for lung cancer. A research team member will consent the individual and record the participants MRN, age, sex, risk factors for lung cancer and their Lung Rads score.
The data collected on this study will be compared to the same data points of participants of the NLST and NELSON studies as well as a cohort of individuals meeting 2021 USPSTF criteria for lung screening participating in a lung screening program at IU Health.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lung disease, COPD, Chronic bronchitis, Emphysema, Pulmonary tuberculosis, Pulmonary fibrosis
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Age: 50 years - 80 years
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Gender: All
Inclusion Criteria
Note: To be eligible, subjects must meet the age requirement, and TWO risk factors and NOT be eligible for LDCT based on USPSTF criteria.
• Age 50 to 80 years at the time of enrollment.
• Have at least two of the following established risk factors for lung cancer including:
o First-degree relative (parent, sibling, child) with lung cancer
o Prior lung disease, specifically COPD, chronic bronchitis, emphysema, history of pulmonary tuberculosis, or pulmonary fibrosis
o Cigarette Risk Factor:
smoking for at least 20 years duration but less than 20 pack-years, regardless of time since last smoked cigarettes
lived in a household for at least 20 years with someone who regularly smoked cigarettes indoors
quit smoking more than 15 years ago
o Exposure:
Exposure to cooking oil fumes or fry cooking without the use of ventilation on average 2 or more days per week for at least 20 years.
Radiation that includes the lung (e.g., neck region, breast, chest wall, cervical or thoracic spine)
Living in a home for at least 10 years with a radon level in the high range [> 4 pCi/L (picocuries per liter) (150 becquerels per meter cubed (Bq/m3) or more]
Living in a home for at least 20 years with a radon level in the moderate range [2-4 pCi/L (75 - 150 Bq/m3).
o Having one or a combination of any high risk (see appendix for list) occupation for ≥10 years:
• Able and willing to provide informed consent
Exclusion Criteria
• Those participating as part of the prospective study must not be eligible for lung screening based on the 2021 USPSTF screening criteria. This criterion includes a 20-pack year or more cigarette smoking history and current smoking or stopped smoking cigarettes fewer than 15 years ago.
• Any medical or psychiatric condition that, in the opinion of the investigators, would compromise informed consent, compliance, or safety.
This study investigates lung screening in individuals at high risk for lung cancer who do not meet the United States Preventive Services Task Force (USPSTF) criteria. Lung cancer is a disease where cells in the lungs grow out of control. The purpose of the study is to understand the demographics, risk factors, and baseline Lung Rads scores of these individuals. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
Participants will undergo lung screening at IU Health sites. They will complete a one-time survey to document their age, sex, and risk factors for lung cancer. A research team member will record each participant's medical information, including their Lung Rads score, which helps in assessing lung cancer risk. This data will be compared with data from other studies to gain insights into the effectiveness of lung screening.
- Who can participate: Individuals aged 50 to 80 years with at least two risk factors for lung cancer are eligible and must not meet the USPSTF criteria for lung cancer screening.
- Study details: Participants will complete a one-time survey and undergo lung screening, during which a research team member will record medical information, including Lung Rads scores, to assess lung cancer risk.
