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NCT Number: NCT00897117

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

Recruiting

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dan Rudy Cancer Center at Saint Thomas Hospital, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

Blood and lung tissue collection

microarray analysis

Genetic

Blood and lung tissue collection

protein expression analysis

Genetic

Blood and lung tissue collection

biologic sample preservation procedure

Other

Blood and lung tissue collection

laboratory biomarker analysis

Other

Blood and lung tissue collection

matrix-assisted laser desorption/ionization time of flight mass spectrometry

Other

Blood and lung tissue collection

Primary outcomes

  1. Protein and RNA expression fingerprints from collected samples

    Time frame: after collection of designated samples

Secondary outcomes

  1. Development of statistical and computational methods to model relationship of data and clinical outcomes

    Time frame: after laboratory gene analysis work is completed

  2. Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival

    Time frame: after collection of designated samples

Study contacts

Contact information is provided by the study sponsor or research team.

VICC Clinical Trials Information Program

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Fingerprinting of Lung Cancer

Important dates

Study start
2001
Primary completion
2031
Study completion
2031
First posted
May 12, 2009
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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