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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: 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

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
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: VICC Clinical Trials Information Program; Phone Number: 800-811-8480; Email: cip@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Completed
      • Dan Rudy Cancer Center at Saint Thomas Hospital
    • Nashville, Tennessee, United States, 37212
      • Suspended
      • Veterans Affairs Medical Center - Nashville
    • Nashville, Tennessee, United States, 37232-6838
      • Recruiting
      • Vanderbilt-Ingram Cancer Center
      • Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center; Phone Number: 800-811-8480

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Protein and RNA expression fingerprints from collected samples	after collection of designated samples

Secondary Outcome Measures

Outcome Measure	Time Frame
Development of statistical and computational methods to model relationship of data and clinical outcomes	after laboratory gene analysis work is completed
Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival	after collection of designated samples

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric Grogan, MD, Vanderbilt Medical Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2001
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2031

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimated): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Investigative Techniques; Genetic Techniques; Microchip Analytical Procedures; Gene Expression Profiling; Microarray Analysis
• Other Study ID Numbers: VICC THO 0136; P30CA068485 (U.S. NIH Grant/Contract); P50CA090949 (U.S. NIH Grant/Contract); VU-VICC-THO-0136 (Other Identifier: VICC)