Identification and Validation of Molecular Markers in Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Identification and Validation of Molecular Markers in Lung Cancer
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Identification of new molecular markers specific to the development of squamous cell lung cancer
Safety Issue:
No
Principal Investigator
Pierre P. Massion, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
Unspecified
Study ID:
CDR0000584223
NCT ID:
NCT00899028
Start Date:
May 2001
Completion Date:
Related Keywords:
- Lung Cancer
- stage 0 non-small cell lung cancer
- stage I non-small cell lung cancer
- extensive stage small cell lung cancer
- limited stage small cell lung cancer
- stage II non-small cell lung cancer
- stage IV non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Lung Neoplasms
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |
