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Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants

Completed
Conditions
Lung Cancer
Registration Number
NCT00899028
Lead Sponsor
Vanderbilt University Medical Center
Brief Summary

RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.

Detailed Description

OBJECTIVES:

* To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.

* To determine the prevalence of candidate biomarkers in lung cancer progression.

* To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions.

* To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients.

OUTLINE: This is a multicenter study.

Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC).

Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results.

Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
689
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Identification of new molecular markers specific to the development of squamous cell lung cancer
Prevalence of candidate biomarkers in lung cancer progression
Odds of developing lung cancer according to biomarker status
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

🇺🇸

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin

🇺🇸

Nashville, Tennessee, United States

Veterans Affairs Medical Center - Nashville

🇺🇸

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

🇺🇸

Nashville, Tennessee, United States

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