Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Proportion of Enrolled Participants
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Screening: Low-Dose Computed Tomography Screening
Participants will undergo study procedures as outlined:
- Complete questionnaires pre- and post- low-dose computed tomography (LDCT) test.
- Visit Massachusetts General Hospital facility for a LDCT screening test.
干预措施: Low-dose Computed Tomography (Procedure)
结局指标
主要结局
Proportion of Enrolled Participants
时间窗: At enrollment
Primary endpoint is feasibility. Feasibility is defined as the percentage of individuals invited to participate in the trial who enroll.
Proportion of Participants with Positive Low-dose Computed Tomography Test
时间窗: 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).
Proportion of Participants Diagnosed with Invasive Lung Cancer
时间窗: 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).
Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores
时间窗: 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).
次要结局
- Proportion of Participants Who Undergo Invasive Diagnostic Procedures(At 6 months)
- Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan(At 6 months)
研究者
Chi-Fu Jeffrey Yang
Principal Investigator
Massachusetts General Hospital