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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/21/2017
Start Date:May 2001
End Date:August 2016

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Identification and Validation of Molecular Markers in Lung Cancer

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.

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.

DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- Known or previously diagnosed lung cancer

- Suspected lung cancer, including the following:

- Completely resected stage I lung cancer (with no evidence of metastatic
disease) for which patient is at risk for developing secondary disease

- Suspected of having lung cancer due to clinical symptoms, such as positive
sputum cytology, hemoptysis, unresolved pneumonia, persistent cough, and
positive x-ray

- Healthy volunteer

PATIENT CHARACTERISTICS:

- WBC ≥ 2,000/mm³ but ≤ 20,000/mm³

- Platelet count ≥ 50,000/mm³

- Not pregnant

- No uncontrolled hypertension (i.e., systolic blood pressure > 200 mm Hg, diastolic
blood pressure > 120 mm Hg)

- No unstable angina

- No known bleeding disorder

- No other contraindications for white light bronchoscopic examination

- No other contraindications for fluorescence examination

PRIOR CONCURRENT THERAPY:

- More than 3 months since prior fluorescent photosensitizing agents (hematoporphyrin
derivatives)

- More than 3 months since prior and no concurrent chemopreventative drugs (e.g.,
tretinoin)

- More than 6 months since prior ionizing radiation treatment to the chest

- More than 6 months since prior systemic cytotoxic chemotherapy

- No concurrent anticoagulant therapy
We found this trial at
4
sites
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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324 Cool Springs Blvd
Nashville, Tennessee 37067
(877) 936-8422
Vanderbilt-Ingram Cancer Center - Cool Springs Vanderbilt-Ingram Cancer Center Cool Springs is a medical oncology...
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Nashville, TN
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2107 Edward Curd Lane
Nashville, Tennessee 37067
615-591-9890
Vanderbilt-Ingram Cancer Center at Franklin The Vanderbilt-Ingram Cancer Center at Franklin is a free-standing radiation...
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Nashville, TN
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Nashville, Tennessee 37212
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Nashville, TN
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