Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer. PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Develop statistical and computational methods for modeling the relationships between multiple variable protein and RNA expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches. Determine protein and RNA expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy. Correlate protein and RNA expression fingerprints with T-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival. OUTLINE: This is a multicenter study. Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis. Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review.

Official Title
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Molecular Fingerprinting of Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: microarray analysis
* Genetic: protein expression analysis
* Other: biologic sample preservation procedure
* Other: laboratory biomarker analysis
* Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosis of non-small cell lung cancer Clinical stage I and II disease Resectable disease and complete surgical resection planned Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network Tumor specimen samples must be available at resection Exclusion criteria Chemotherapy before surgery Radiotherapy before surgery

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resectable non-small cell lung cancer<br>Patients with clinical stage I or II invasive lung cancer that can be completely removed by surgery and who have not undergone chemotherapy or radiotherapy before surgery | Genetic: gene expression analysis<br>* Blood and lung tissue collection<br>Genetic: microarray analysis<br>* Blood and lung tissue collection<br>Genetic: protein expression analysis<br>* Blood and lung tissue collection<br>Other: biologic sample preservation procedure<br>* Blood and lung tissue collection<br>Other: laboratory biomarker analysis<br>* Blood and lung tissue collection<br>Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry<br>* Blood and lung tissue collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein and RNA expression fingerprints from collected samples |  | after collection of designated samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of statistical and computational methods to model relationship of data and clinical outcomes |  | after laboratory gene analysis work is completed | 
| Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival |  | after collection of designated samples | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer