Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer. PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.

Detailed Description
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OBJECTIVES: To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression. To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung. OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

Official Title
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Molecular Predictors of Lung Cancer Behavior: Controls

Conditions
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Lung Cancer, Healthy, no Evidence of Disease

Intervention / Treatment
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* Genetic: proteomic profiling
* Other: biologic sample preservation procedure
* Other: laboratory biomarker analysis
* Procedure: bronchoscopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Healthy participant No history of smoking No history of cancer PATIENT CHARACTERISTICS: SWOG performance status 0 No clinically apparent bleeding diathesis PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy, non-smokers<br> | Genetic: proteomic profiling<br>* Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath<br>Other: biologic sample preservation procedure<br>* Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath<br>Other: laboratory biomarker analysis<br>* Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath<br>Procedure: bronchoscopy<br>* Collection of breath condensate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of biological specimens to use as controls in the study of lung cancer progression | Specimens are collected from healthy participants with no known risk of lung cancer | Off study date, up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung |  | off-study date, up to one year | 
| Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers |  | off-study date, up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell lung cancer, non-small cell lung cancer, small cell lung cancer, healthy, no evidence of disease