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

Официальное название

Molecular Fingerprinting of Lung Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Генная терапия gene expression analysis
  Blood and lung tissue collection
• Генная терапия microarray analysis
  Blood and lung tissue collection
• Генная терапия protein expression analysis
  Blood and lung tissue collection
• Другое biologic sample preservation procedure
  Blood and lung tissue collection
• Другое laboratory biomarker analysis
  Blood and lung tissue collection
• Другое matrix-assisted laser desorption/ionization time of flight mass spectrometry
  Blood and lung tissue collection

Первичные конечные точки

• Protein and RNA expression fingerprints from collected samples [Срок оценки: after collection of designated samples]

Вторичные конечные точки (2)

• Development of statistical and computational methods to model relationship of data and clinical outcomes [Срок оценки: after laboratory gene analysis work is completed]
• Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival [Срок оценки: after collection of designated samples]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Chemotherapy before surgery
• Radiotherapy before surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• Dan Rudy Cancer Center at Saint Thomas Hospital — Nashville
• Veterans Affairs Medical Center - Nashville — Nashville
• Vanderbilt-Ingram Cancer Center — Nashville

Идентификаторы

NCT: NCT00897117 · VICC THO 0136 · P50CA090949 · VU-VICC-THO-0136 · P30CA068485

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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