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Clinical Trials/NCT00899028
NCT00899028
Completed
Not Applicable

Identification and Validation of Molecular Markers in Lung Cancer

Vanderbilt University Medical Center4 sites in 1 country689 target enrollmentMay 2001
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Vanderbilt University Medical Center
Enrollment
689
Locations
4
Primary Endpoint
Identification of new molecular markers specific to the development of squamous cell lung cancer
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2001
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pierre P. Massion

Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (4)

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