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

• Sponsor: Vanderbilt-Ingram Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00897117
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 4,000
• Locations: 3
• Duration (Months): 290
• Patients Per Site: 1333.3
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	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 Design

• Study Type: Observational
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Molecular Fingerprinting of Lung Cancer
• Study Start Date: May 1, 2001
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. Protein and RNA expression fingerprints from collected samples [after collection of designated samples]

Secondary Outcome Measures

1. Development of statistical and computational methods to model relationship of data and clinical outcomes [after laboratory gene analysis work is completed]

2. Correlation of protein and RNA expression fingerprints with recurrence (local and/or distant) and survival [after collection of designated samples]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dan Rudy Cancer Center at Saint Thomas Hospital	Nashville	Tennessee	United States	37205
2	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee	United States	37212
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838

Sponsors and Collaborators

• Vanderbilt-Ingram Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Eric Grogan, MD, Vanderbilt Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Publications

None provided.

• Responsible Party: Eric Grogan, Associate Professor of Thoracic Surgery, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT00897117
• Other Study ID Numbers: VICC THO 0136; P50CA090949; VU-VICC-THO-0136; P30CA068485
• First Posted: May 12, 2009
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Eric Grogan, Associate Professor of Thoracic Surgery, Vanderbilt-Ingram Cancer Center: stage I non-small cell lung cancer; stage II non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Apr 27, 2022