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

Recruiting

• Conditions: Lung Cancer
• 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

• Registration Number: NCT00897117
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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 Timeline

• Study Start: 2001-05
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2031-05-31
• Study Completion: 2031-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resectable non-small cell lung cancer	gene expression analysis	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
Resectable non-small cell lung cancer	microarray analysis	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
Resectable non-small cell lung cancer	protein expression analysis	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
Resectable non-small cell lung cancer	biologic sample preservation procedure	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
Resectable non-small cell lung cancer	laboratory biomarker analysis	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
Resectable non-small cell lung cancer	matrix-assisted laser desorption/ionization time of flight mass spectrometry	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

Primary Outcome Measures

Name	Time	Method
Protein and RNA expression fingerprints from collected samples	after collection of designated samples

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

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

Veterans Affairs Medical Center - Nashville; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States