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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: June 23, 2014
Last verified: December 2013
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Fingerprinting of Lung Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Protein and RNA expression fingerprints from collected samples [ Time Frame: after collection of designated samples ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Both prospective and retrospectives samples of blood and tissue.


Estimated Enrollment: 1200
Study Start Date: May 2001
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897117

Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480

Locations
United States, Tennessee
Dan Rudy Cancer Center at Saint Thomas Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: Contact Person    615-222-2166      
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Clinical Trials Information Program    800-811-8480      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Clinical Trials Information Program    800-811-8480      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Veterans Affairs Medical Center - Nashville Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas    615-327-4751      
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Pierre P. Massion, MD, Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897117     History of Changes
Other Study ID Numbers: VICC THO 0136, P50CA090949, VU-VICC-THO-0136, P30CA068485
Study First Received: May 9, 2009
Last Updated: June 23, 2014
Health Authority: Unites States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014