Official Title: “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.
- Study Type: Observational
- Study Design: N/A
- Study Primary Completion Date: May 2011
Detailed Clinical Trial Description
- 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.
Interventions Used in this Clinical Trial
- Genetic: comparative genomic hybridization
- Genetic: fluorescence in situ hybridization
- Genetic: gene expression analysis
- Genetic: microarray analysis
- Genetic: protein expression analysis
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
- Other: medical chart review
- Procedure: diagnostic bronchoscopy
Outcome Measures for this Clinical Trial
- Identification of new molecular markers specific to the development of squamous cell lung cancer
- Safety Issue?: No
- Prevalence of candidate biomarkers in lung cancer progression
- Safety Issue?: No
- Odds of developing lung cancer according to biomarker status
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
- 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
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers
Clinical Trial Investigator Information
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- Overall Official(s)
- Pierre P. Massion, MD, Study Chair, Vanderbilt-Ingram Cancer Center