NCT03628638已完成不适用
2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,718
- 试验地点
- 31
- 主要终点
- Biomarker Identification
研究概览
简要总结
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
详细描述
Subjects will be participating in a lung cancer screening program at enrollment. Subjects will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up may have another blood draw at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female, 50 years of age or older.
- •Subject meets one of two lung cancer screening criteria below.
- •Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR
- •Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules).
- •Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
排除标准
- •Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded).
- •Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
- •Prior removal of the lung, excluding percutaneous lung biopsy.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
结局指标
主要结局
Biomarker Identification
时间窗: 27 months
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
次要结局
未报告次要终点
研究者
研究点 (31)
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