Low-dose Computed Tomography
ProcedurePer standard care
NCT Number: NCT05898594
The goal of this research study is to study U.S. Black individuals with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population.
The name of the intervention used in this research study is:
Low-dose computed tomography (radiologic scan) chest scan
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
University of Chicago, Chicago, Illinois, United States
The goal of this single-arm pilot research study is to evaluate the feasibility and acceptability of low-dose computed tomography (LDCT) screening for lung cancer among U.S. Black individuals with a history of smoking.
LDCT screening is currently the only recommended way to screen for lung cancer among high-risk individuals. However, many Black individuals at high-risk for lunch cancer are currently ineligible for lung cancer screening.
Study procedures include screening for eligibility, completion of questionnaires, and a LDCT screening test.
Participation in this study is expected to last up to 3 months.
It is expected about 900 people will participate in this study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Per standard care
Time frame: At enrollment
Primary endpoint is feasibility. Feasibility is defined as the percentage of individuals invited to participate in the trial who enroll.
Time frame: At 3 months
The percentage of participants who have a positive low-dose computed tomography test will be evaluated. This percentage will be compared to the Black individuals randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control).
Time frame: At 6 months
The proportion of participants with a lung cancer diagnosis post-low-dose computed tomography screening test will be compared to Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).
Time frame: At 3 months
The distribution of Lung-RADS scores among participants will be evaluated and compared to the distribution of Lung-RADS scores among Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).
Time frame: At 6 months
The proportion of participants who undergo invasive diagnostic procedures will be evaluated and compared to the proportion of Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control) who underwent invasive diagnostic procedures.
Time frame: At 6 months
The proportion of participants who have a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan will be evaluated. This proportion will be compared to the proportion of Black individuals randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control) who had a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Individuals
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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