Identification of a Plasma Proteomic Signature for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 12
- 主要终点
- Incidence rate of Non-Small Cell Lung Cancer
研究概览
简要总结
The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.
详细描述
Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.
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
- •any smoking status, e.g. current, former, or never
- •co-morbid conditions, e.g. COPD
- •Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity
- •Pathology: malignant - adenocarcinoma, squamous, or large cell
- •Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory (e.g. hamartoma)
- •Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B)
- •Clinical stage, Regional lymph nodes: N0 or N1 only
- •Clinical stage, Distant metastasis: M0 only
排除标准
- •prior malignancy within 5 years of lung nodule diagnosis
- •No nodule size available
- •No pathology data available for those with
- •Current diagnosis of non-small cell lung cancer
- •Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1
结局指标
主要结局
Incidence rate of Non-Small Cell Lung Cancer
时间窗: 24 months after enrollment
The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.
次要结局
- Panel of proteins(At the end of the study)