Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 15
- 主要终点
- Lung Cancer
研究概览
简要总结
The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.
详细描述
The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that includes 7 Veterans Administration Hospitals (VAH), the 4 designated Military Treatment Facilities (MTF) and 4 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores. The DECAMP Coordinating Center will facilitate rapid selection, design and execution of clinical studies within this multi-institutional consortium. The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging & molecular markers) that results in the most robust diagnostic predictor will be evaluated.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45 years of age or older;
- •Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
- •Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
- •Willing to undergo fiberoptic bronchoscopy;
- •Able to tolerate all biospecimen collection as required by protocol;
- •Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for a minimum of two years;
- •Able to fill out Patient Lung History questionnaire;
- •Willing and able to provide a written informed consent.
排除标准
- •History or previous diagnosis of lung cancer;
- •Diagnosis of pure ground glass opacities on chest CT;
- •Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
- •Allergies to any local anesthetic that may be used to obtain biosamples in the study.
结局指标
主要结局
Lung Cancer
时间窗: 2 years
Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.
次要结局
未报告次要终点