Molecular Predictors of Lung Cancer Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 4
- 主要终点
- To quantitate the molecular changes during lung cancer development
研究概览
简要总结
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.
详细描述
OBJECTIVES:
- To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
- To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.
OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.
Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.
排除标准
- •Inability to provide informed consent
- •Pregnant women
研究组 & 干预措施
Sample Collection
干预措施: comparative genomic hybridization (Genetic)
Sample Collection
干预措施: gene expression microarray analysis (Genetic)
Sample Collection
干预措施: proteomic profiling analysis (Genetic)
Sample Collection
干预措施: biologic sample preservation procedure (Other)
Sample Collection
干预措施: nasal brushing (Procedure)
Sample Collection
干预措施: Blood draw (Procedure)
Sample Collection
干预措施: Urine collection (Procedure)
Sample Collection
干预措施: sputum sample (Procedure)
Sample Collection
干预措施: fluorescence bronchoscopy with airway biopsy (Procedure)
Sample Collection
干预措施: fine needle aspiration of the lung (Procedure)
Sample Collection
干预措施: thoracentesis (Procedure)
结局指标
主要结局
To quantitate the molecular changes during lung cancer development
时间窗: After collection of designated samples
As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up. Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met.
次要结局
- Develop a method to diagnose and stage pre-invasive and invasive lesions(After collection of designated samples)
研究者
Fabien Maldonado
Professor of Medicine and Thoracic Surgery
Vanderbilt-Ingram Cancer Center