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

This study is currently recruiting participants.
Verified August 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897117
First received: May 9, 2009
Last updated: August 27, 2013
Last verified: August 2013

May 9, 2009
August 27, 2013
May 2001
July 2015   (final data collection date for primary outcome measure)
Protein and RNA expression fingerprints from collected samples [ Time Frame: after collection of designated samples ] [ Designated as safety issue: No ]
  • Protein and RNA expression fingerprints from collected samples [ Designated as safety issue: No ]
  • Development of statistical and computational methods to model relationship of data and clinical outcomes [ Designated as safety issue: No ]
  • Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897117 on ClinicalTrials.gov Archive Site
  • Development of statistical and computational methods to model relationship of data and clinical outcomes [ Time Frame: after laboratory gene analysis work is completed ] [ Designated as safety issue: No ]
  • Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival [ Time Frame: after collection of designated samples ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
Molecular Fingerprinting of Lung Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Both prospective and retrospectives samples of blood and tissue.

Probability Sample

People who have clinical stage I and II non-small cell lung cancer

Lung Cancer
  • Genetic: gene expression analysis
    Blood and lung tissue collection
  • Genetic: microarray analysis
    Blood and lung tissue collection
  • Genetic: protein expression analysis
    Blood and lung tissue collection
  • Other: biologic sample preservation procedure
    Blood and lung tissue collection
  • Other: laboratory biomarker analysis
    Blood and lung tissue collection
  • Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
    Blood and lung tissue collection
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
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
NCT00897117
VICC THO 0136, P50CA090949, VU-VICC-THO-0136, P30CA068485
No
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP