Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.

Detailed Description
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OBJECTIVES: To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung. To determine the prevalence of candidate biomarkers in lung cancer progression. To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions. To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients. OUTLINE: This is a multicenter study. Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC). Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results. Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.

Official Title
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Identification and Validation of Molecular Markers in Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Genetic: comparative genomic hybridization
* Genetic: fluorescence in situ hybridization
* Genetic: gene expression analysis
* Genetic: microarray analysis
* Genetic: protein expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
* Other: medical chart review
* Procedure: diagnostic bronchoscopy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Known or previously diagnosed lung cancer Suspected lung cancer, including the following: Completely resected stage I lung cancer (with no evidence of metastatic disease) for which patient is at risk for developing secondary disease Suspected of having lung cancer due to clinical symptoms, such as positive sputum cytology, hemoptysis, unresolved pneumonia, persistent cough, and positive x-ray Healthy volunteer PATIENT CHARACTERISTICS: WBC ≥ 2,000/mm³ but ≤ 20,000/mm³ Platelet count ≥ 50,000/mm³ Not pregnant No uncontrolled hypertension (i.e., systolic blood pressure > 200 mm Hg, diastolic blood pressure > 120 mm Hg) No unstable angina No known bleeding disorder No other contraindications for white light bronchoscopic examination No other contraindications for fluorescence examination PRIOR CONCURRENT THERAPY: More than 3 months since prior fluorescent photosensitizing agents (hematoporphyrin derivatives) More than 3 months since prior and no concurrent chemopreventative drugs (e.g., tretinoin) More than 6 months since prior ionizing radiation treatment to the chest More than 6 months since prior systemic cytotoxic chemotherapy No concurrent anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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

| Intervention/Treatment |
| --- |
|Genetic: comparative genomic hybridization|nan|
|Genetic: fluorescence in situ hybridization|nan|
|Genetic: gene expression analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: protein expression analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry|nan|
|Other: medical chart review|nan|
|Procedure: diagnostic bronchoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of new molecular markers specific to the development of squamous cell lung cancer |  |  | 
| Prevalence of candidate biomarkers in lung cancer progression |  |  | 
| Odds of developing lung cancer according to biomarker status |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage 0 non-small cell lung cancer, stage I non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage II non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer