NCT00900419招募中不适用
Biomarkers and Dysplastic Respiratory Epithelium
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Genetic mutations or altered growth factor expression
研究概览
简要总结
RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer.
详细描述
OBJECTIVES:
Primary
- Determine intermediate biomarkers of premalignant respiratory epithelial lesions, such as genetic mutations or altered growth factor expression, in patients with dysplasia of the respiratory epithelium or lung cancer, head and neck cancer, or aerodigestive tract cancer.
Secondary
- Establish a tissue repository of normal and dysplastic respiratory epithelium from endobronchial forceps and brush biopsy tissue from these patients and from normal volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of extensive and severe dysplasia of the respiratory epithelium
- •Those without dysplasia of the respiratory epithelium
- •Recruited from the SPORE Tissue Procurement Screening Project or by private or academic physicians (for patients with moderate or severe dysplasia)
- •Survived 1 or more aerodigestive system carcinoma for ≥ 1 year
- •Completely resected stage I non-small cell cancer
- •Undergoing any of the following procedures:
- •Routine panendoscopy for patients with head and neck cancer
- •Resection of a bronchogenic carcinoma
- •Bronchoscopy for diagnosis or staging of suspected lung cancer
- •Subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment in patients with prior high-grade dysplasia or worse
- •No asthma
- •No lung disease
- •No respiratory illness within the past 2 weeks Patients suspected of or at risk for neoplastic lung disease who are undergoing a bronchoscopy in which differential diagnostic considerations may include multiple other etiologies such as infection and other processes.
- •Patients without dysplasia will be: patients undergoing clinically indicated bronchoscopy for conditions other than suspected lung cancer.
- •PATIENT CHARACTERISTICS:
- •No clinically apparent bleeding diathesis
- •No known bleeding disorder
- •No anginal
- •No clinically active coronary artery disease
- •No multifocal premature ventricular contractions
- •No poorly controlled congestive heart failure
- •No myocardial infarction within the past 6 weeks
- •No cardiac dysrhythmia that is potentially life threatening
- •Well-controlled atrial fibrillation or rare (< 2/min) premature ventricular contractions allowed
- •No ventricular tachycardia or supraventricular tachycardia with a rapid ventricular response
- •No other serious medical condition that would preclude a patient from undergoing a bronchoscopy
- •No acute bronchitis or pneumonia within the past 8 weeks except when clinically proven as a possible result of lung cancer
- •No hypoxemia (i.e., < 90% saturation with supplemental oxygen) before bronchoscopy
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Genetic mutations or altered growth factor expression
时间窗: After study has completed
次要结局
- Establishment of a tissue repository of normal and dysplastic respiratory epithelium(After study has closed)
研究者
研究点 (1)
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