Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
NCT ID: NCT00897117
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2001-05-31
2031-05-31
Brief Summary
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PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Resectable non-small cell lung cancer
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
gene expression analysis
Blood and lung tissue collection
microarray analysis
Blood and lung tissue collection
protein expression analysis
Blood and lung tissue collection
biologic sample preservation procedure
Blood and lung tissue collection
laboratory biomarker analysis
Blood and lung tissue collection
matrix-assisted laser desorption/ionization time of flight mass spectrometry
Blood and lung tissue collection
Interventions
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gene expression analysis
Blood and lung tissue collection
microarray analysis
Blood and lung tissue collection
protein expression analysis
Blood and lung tissue collection
biologic sample preservation procedure
Blood and lung tissue collection
laboratory biomarker analysis
Blood and lung tissue collection
matrix-assisted laser desorption/ionization time of flight mass spectrometry
Blood and lung tissue collection
Eligibility Criteria
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Inclusion Criteria
* 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
* Radiotherapy before surgery
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Eric Grogan
Associate Professor of Thoracic Surgery
Principal Investigators
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Eric Grogan, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Locations
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Dan Rudy Cancer Center at Saint Thomas Hospital
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Role: primary
Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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