Lung B.A.S.E.S 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Assessing Incidence and Stage of Lung Cancer Diagnosis in Subjects Ages 40-54 With a 30 Pack Year History or More Within North and South Carolina
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,160
- 试验地点
- 2
- 主要终点
- Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.
研究概览
简要总结
Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk population.
详细描述
The primary objective of this study is to evaluate the lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT. Secondary objectives include evaluating the lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2); evaluating the positive screening rate at T0, T1, and T2; evaluating the impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates; and summarizing the incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening. Enrollment will continue until 174 subjects are identified in the evaluable population with a total of 1160 subjects anticipated to be enrolled and screened.
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
- 40 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must meet all the following applicable inclusion criteria to participate in this study:
- •Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- •Age 40-54 years at the time of consent.
- •A positive smoking history of greater/equal to 30 pack years and they are either currently smoking or have quit within the last 15 years.
- •Ability to read and understand the English and/or Spanish language.
- •Ability to understand and comply with study procedures for the entire length of the study.
排除标准
- •Subjects meeting any of the criteria below may not participate in the study:
- •Known diagnosis of lung cancer in the past 5 years.
- •Any known contraindication to having a low-dose CT Scan.
- •Known pregnancy.
研究组 & 干预措施
Single Arm
Mobile Low-dose Computed Tomography (LDCT) Screening
干预措施: Mobile Low-dose Computed Tomography (LDCT) Screening (Other)
结局指标
主要结局
Lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (T0) with mobile low-dose CT.
时间窗: 1 day
The lung cancer diagnosis variable will be determined for each subject as a binary variable indicating whether or not the subject's T0 screening results in a diagnosis of lung cancer.
次要结局
- Positive screening rate at T0, T1, and T2(up to 24 months)
- Impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates(up to 24 months)
- Incidence rate of all types of cancer found with low-dose lung CT during lung cancer screening(up to 24 months)
- Lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (T1 and T2)(up to 24 months)