NYU Lung Cancer Biomarker Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,606
- 试验地点
- 1
- 主要终点
- Lung cancer diagnosis as measured by CT scan findings and pathology findings annually
研究概览
简要总结
RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer.
PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.
详细描述
OBJECTIVES:
- Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
- Identify preneoplastic cellular changes and lesions in these patients.
OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk).
Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy.
Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy.
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
- •DISEASE CHARACTERISTICS:
- •Screening Cohort
- •At high- or low-risk for lung cancer
- •Smoking history ≥ 20 pack years*
- •With or without workplace exposure to asbestos
- •NOTE: * Participants with < 20 pack years of smoking are eligible if 50 years of age or older
- •Rule-Out Lung cancer group
- •Referred for evaluation of suspicious nodules with 1 of the following diagnoses:
- •Lung cancer
- •Nonmalignant nodules (control group)
- •PATIENT CHARACTERISTICS:
- •Not pregnant
- •No prior malignancy except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Lung cancer diagnosis as measured by CT scan findings and pathology findings annually
时间窗: 07/01/2015
次要结局
- Precancerous lung nodules as measured by CT scan findings and pathology findings annually(07/01/2015)