Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 684
- 试验地点
- 33
- 主要终点
- Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
研究概览
简要总结
This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.
详细描述
Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 years
- •Smoking history: Never, Former, Current
- •Subject undergoing diagnostic evaluation for a lung nodule
- •Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
- •Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
- •Nodule(s) identified by CT scan previously not followed
- •Subject willing to provide informed consent for the collection of blood specimens
排除标准
- •Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
- •A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance
- •Current diagnosis of any cancer
- •Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
- •Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
- •History of human immunodeficiency virus (HIV) or Hepatitis C
结局指标
主要结局
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
时间窗: 2 years post enrollment
Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
次要结局
未报告次要终点