跳至主要内容
临床试验/NCT00898313
NCT00898313
招募中
不适用

Molecular Predictors of Lung Cancer Behavior

Vanderbilt-Ingram Cancer Center4 个研究点 分布在 1 个国家目标入组 4,000 人2003年12月1日

概览

阶段
不适用
干预措施
comparative genomic hybridization
疾病 / 适应症
Lung Cancer
发起方
Vanderbilt-Ingram Cancer Center
入组人数
4000
试验地点
4
主要终点
To quantitate the molecular changes during lung cancer development
状态
招募中
最后更新
5天前

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.

注册库
clinicaltrials.gov
开始日期
2003年12月1日
结束日期
2027年1月31日
最后更新
5天前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Fabien Maldonado

Professor of Medicine and Thoracic Surgery

Vanderbilt-Ingram Cancer Center

入排标准

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

Sample Collection

干预措施: gene expression microarray analysis

Sample Collection

干预措施: proteomic profiling analysis

Sample Collection

干预措施: biologic sample preservation procedure

Sample Collection

干预措施: nasal brushing

Sample Collection

干预措施: Blood draw

Sample Collection

干预措施: Urine collection

Sample Collection

干预措施: sputum sample

Sample Collection

干预措施: fluorescence bronchoscopy with airway biopsy

Sample Collection

干预措施: fine needle aspiration of the lung

Sample Collection

干预措施: thoracentesis

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)

研究点 (4)

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