Lung Cancer Screening in High-risk Black Individuals
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorMassachusetts General Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-identified Black individual.
Have a self-reported history of smoking. No restriction will be placed on the number of smoking pack years participants must have nor the number of years former smokers must have quit smoking.
Aged 50-80 years.
Disqualifiers
Individuals with a history of lung cancer.
Individuals with symptoms suggestive of lung cancer. We will evaluate whether individuals have symptoms suggestive of lung cancer by administering an online screening questionnaire, which will ask whether they have experienced shortness of breath, whether they become easily winded, and whether they have had a chronic cough within the last 12 weeks that has not improved. Individuals who select that they have any one of these symptoms will be advised to follow up with their primary doctor and will not be eligible to participate in the study.
Individuals with pneumonia or acute respiratory infection within 12 weeks prior to enrollment that was treated with antibiotics.
Trial design
Design model
Single group
Treatments tested in this trial
Low-dose Computed Tomography
Procedure/SurgeryPer standard care
Treatment groups
900 Participants
are divided into 1 treatment groupGroup A: Screening: Low-Dose Computed Tomography ScreeningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Enrolled Participants
Primary endpoint is feasibility. Feasibility is defined as the percentage of individuals invited to participate in the trial who enroll.
Time frame
At enrollment2
Proportion of Participants with Positive Low-dose Computed Tomography Test
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 3 months3
Proportion of Participants Diagnosed with Invasive Lung Cancer
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 6 months4
Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores
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 3 monthsSecondary outcomes
1
Proportion of Participants Who Undergo Invasive Diagnostic Procedures
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 months2
Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan
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.
Time frame
At 6 monthsSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
Source ClinicalTrials.gov