Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers
Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).
研究概览
地位
详细说明
OBJECTIVES:
- To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.
- To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.
OUTLINE: This is a multicenter study.
Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.
All study participants are followed annually.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Wales
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Llanelli、Wales、英国、SA14 8QF
- 招聘中
- Prince Philip Hospital
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接触：
- Contact Person
- 电话号码：44-1554-75-65-67
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Swansea、Wales、英国、SA2 8PP
- 招聘中
- South West Wales Cancer Institute
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接触：
- Paul D. Lewis, BSc, PhD
- 电话号码：44-1792-295-222
- 邮箱：p.d.lewis@swansea.ac.uk
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- Diagnosis of lung cancer
- At high risk for developing lung cancer
- Non-high-risk smoking or non-smoking volunteer (control)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
学习计划
研究是如何设计的？
研究衡量的是什么？
主要结果指标
结果测量 |
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Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people
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Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
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合作者和调查者
调查人员
- 首席研究员：Paul D. Lewis, BSc, PhD、Swansea University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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