Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00897117|
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : August 23, 2017
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.
|Condition or disease||Intervention/treatment|
|Lung Cancer||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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Molecular Fingerprinting of Lung Cancer|
|Study Start Date :||May 2001|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
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
Genetic: gene expression analysis
Blood and lung tissue collectionGenetic: microarray analysis
Blood and lung tissue collectionGenetic: protein expression analysis
Blood and lung tissue collectionOther: biologic sample preservation procedure
Blood and lung tissue collectionOther: laboratory biomarker analysis
Blood and lung tissue collectionOther: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Blood and lung tissue collection
- Protein and RNA expression fingerprints from collected samples [ Time Frame: after collection of designated samples ]
- Development of statistical and computational methods to model relationship of data and clinical outcomes [ Time Frame: after laboratory gene analysis work is completed ]
- Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival [ Time Frame: after collection of designated samples ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897117
|Contact: VICC Clinical Trials Information Program||800-811-8480|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Withdrawn|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Withdrawn|
|Nashville, Tennessee, United States, 37064|
|Dan Rudy Cancer Center at Saint Thomas Hospital||Completed|
|Nashville, Tennessee, United States, 37205|
|Veterans Affairs Medical Center - Nashville||Completed|
|Nashville, Tennessee, United States, 37212|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232-6838|
|Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480|
|Principal Investigator:||Pierre P. Massion, MD||Vanderbilt-Ingram Cancer Center|