Lung Cancer Screening in High-risk Black Individuals

Massachusetts General Hospital900 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

900

Conditions

Lung Cancer Lung Carcinoma

Interventions

Low-dose Computed TomographyPROCEDURE

Per standard care

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 years. Exclusion Criteria: * 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.

Locations (2)

University of Chicago

Chicago, Illinois, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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 enrollment

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 months

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 months

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 months

Secondary Outcomes

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 months

Central Contacts

Chi Fu Jeffrey Yang, MD

CONTACT

617-724-1681 cjyang@mgh.harvard.edu

Data from ClinicalTrials.gov

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