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

NCT ID: NCT00897117

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-31

Study Completion Date

2031-05-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

gene expression analysis

Intervention Type GENETIC

Blood and lung tissue collection

microarray analysis

Intervention Type GENETIC

Blood and lung tissue collection

protein expression analysis

Intervention Type GENETIC

Blood and lung tissue collection

biologic sample preservation procedure

Intervention Type OTHER

Blood and lung tissue collection

laboratory biomarker analysis

Intervention Type OTHER

Blood and lung tissue collection

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

Intervention Type OTHER

Blood and lung tissue collection

Interventions

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gene expression analysis

Blood and lung tissue collection

Intervention Type GENETIC

microarray analysis

Blood and lung tissue collection

Intervention Type GENETIC

protein expression analysis

Blood and lung tissue collection

Intervention Type GENETIC

biologic sample preservation procedure

Blood and lung tissue collection

Intervention Type OTHER

laboratory biomarker analysis

Blood and lung tissue collection

Intervention Type OTHER

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

Blood and lung tissue collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Eric Grogan

Associate Professor of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Grogan, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Medical Center

Locations

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Dan Rudy Cancer Center at Saint Thomas Hospital

Nashville, Tennessee, United States

Site Status COMPLETED

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, United States

Site Status SUSPENDED

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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VICC Clinical Trials Information Program

Role: CONTACT

800-811-8480

Facility Contacts

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Clinical Trials Office - Vanderbilt-Ingram Cancer Center

Role: primary

800-811-8480

Related Links

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http://www.vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

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P50CA090949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-THO-0136

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC THO 0136

Identifier Type: -

Identifier Source: org_study_id

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