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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 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date August 24, 2018
Study Start Date May 2001
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2013)
Protein and RNA expression fingerprints from collected samples [ Time Frame: after collection of designated samples ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Development of statistical and computational methods to model relationship of data and clinical outcomes
  • Protein and RNA expression fingerprints from collected samples
  • Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival
Change History Complete list of historical versions of study NCT00897117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 22, 2013)
  • 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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
Official Title Molecular Fingerprinting of Lung Cancer
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Both prospective and retrospectives samples of blood and tissue.
Sampling Method Probability Sample
Study Population People who have clinical stage I and II non-small cell lung cancer
Condition Lung Cancer
Intervention
  • 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
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2018)
4000
Original Estimated Enrollment
 (submitted: May 9, 2009)
600
Estimated Study Completion Date July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00897117
Other Study ID Numbers VICC THO 0136
P50CA090949 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0136 ( Other Identifier: VICC )
P30CA068485 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor Vanderbilt-Ingram Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date August 2018