Nashville Early Diagnosis Lung Cancer Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- To compare candidate biomarkers over time among participants who did and did not develop lung cancer
研究概览
简要总结
This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies.
The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis.
The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.
详细描述
It is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). The expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. All individuals benefit from clinic visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.
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
- •55 - 80 years of age
- •Current smoker or former smoker. If former smoker, must have quit smoking less than 15 years ago
- •>/= 30 pack year of smoking history
排除标准
- •History of diagnosis/treatment of lung cancer in the past 2 years
- •History of head/neck or esophageal cancer in the last 1 year
- •Inability to provide informed consent
- •Participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (DVT, mechanical heart valves, unstable coronary syndrome, etc.)
结局指标
主要结局
To compare candidate biomarkers over time among participants who did and did not develop lung cancer
时间窗: at baseline and yearly to year 5
Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly screening results will be compared in the two groups.
次要结局
- To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions.(at baseline and yearly to year 5)
- To assess changes in prevalence and grade of pre-invasive lesions in this cohort.(baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months))
- To describe patients eligible for future chemoprevention clinical trials.(at year 5)
研究者
Eric Grogan
Associate Professor - Thoracic Surgery
Vanderbilt-Ingram Cancer Center