Prospective Longitudinal Blinded Observational Diagnostic Study - Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 4
- 主要终点
- Specificity of HMBDx microRNA Test for Lung Cancer
研究概览
简要总结
To demonstrate that the specificity of the Hummingbird microRNA profile for the diagnosis of lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer screening in the U.S. is superior to the specificity of LDCT.
详细描述
This is a prospective, longitudinal, blinded, observational diagnostic study on 400 individuals undergoing lung cancer screening with low-dose computed tomography (LDCT).
There will be two patient cohorts: Cohort 1: individuals undergoing their first or subsequent annual LDCT screening study; and Cohort 2: individuals referred for a follow-up diagnostic chest CT scan due to a lung-RADS category 3 or 4 result on a previous LDCT scan.
At study enrollment a blood sample will be drawn prior to the LDCT scan. On this blood sample a novel lung cancer test relying on microRNA signatures will be evaluated. The results will be compared with the CT scan results and follow-up tests including pathology. Histologic results and follow-up data will be collected on all patients for a minimum of 12 months post-enrollment. During the follow-up period, the results of all diagnostic chest CT scans, lung biopsies or lung resections will be captured from the Partners electronic medical record and entered into the case report form (CRF).
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing LDCT screening for lung cancer.
- •Subject is 55 to 80 years of age.
- •Subject has a minimum 30 pack-year smoking history.
- •Subject has not quit smoking more than 15 years ago.
- •Subject is without symptoms attributable to lung cancer.
- •Subject is able and willing to provide informed consent.
排除标准
- •Subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years.
- •Subject is known to be infected with HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III) pathogen infections.
结局指标
主要结局
Specificity of HMBDx microRNA Test for Lung Cancer
时间窗: 12 months
The reference standard will be the combination of all available diagnostic information (LDCT, subsequent diagnostic imaging studies, biopsy results and surgical pathology results) obtained during at least 12 months of follow-up.
次要结局
未报告次要终点