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

Lung Cancer Clinical Trial

Official title:

Molecular Fingerprinting of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00897117
• Other study ID #: VICC THO 0136
• Secondary ID: P50CA090949VU-VI
• Status: Recruiting
• Start date: May 2001
• Est. completion date: May 31, 2031

Study information

• Verified date: May 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: VICC Clinical Trials Information Program
• Phone: 800-811-8480
• Email: cip[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: May 31, 2031
• Est. primary completion date: May 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• gene expression analysis
Blood and lung tissue collection
• microarray analysis
Blood and lung tissue collection
• protein expression analysis
Blood and lung tissue collection

Other:
• biologic sample preservation procedure
Blood and lung tissue collection
• laboratory biomarker analysis
Blood and lung tissue collection
• matrix-assisted laser desorption/ionization time of flight mass spectrometry
Blood and lung tissue collection

Locations

Country	Name	City	State
United States	Dan Rudy Cancer Center at Saint Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein and RNA expression fingerprints from collected samples		after collection of designated samples
Secondary	Development of statistical and computational methods to model relationship of data and clinical outcomes		after laboratory gene analysis work is completed
Secondary	Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival		after collection of designated samples

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial