RecruitingNCT00900419
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Biomarkers and Dysplastic Respiratory Epithelium
Sponsor
University of Colorado, Denver
Enrollment
700 participants
Start Date
May 3, 2001
Study Type
OBSERVATIONAL
Conditions
Summary
RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer.
Eligibility
Min Age: 21 YearsMax Age: 90 Years
Inclusion Criteria30
- Diagnosis of extensive and severe dysplasia of the respiratory epithelium
- Those without dysplasia of the respiratory epithelium
- Recruited from the SPORE Tissue Procurement Screening Project or by private or academic physicians (for patients with moderate or severe dysplasia)
- Survived 1 or more aerodigestive system carcinoma for ≥ 1 year
- Completely resected stage I non-small cell cancer
- Undergoing any of the following procedures:
- Routine panendoscopy for patients with head and neck cancer
- Resection of a bronchogenic carcinoma
- Bronchoscopy for diagnosis or staging of suspected lung cancer
- Subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment in patients with prior high-grade dysplasia or worse
- No asthma
- No lung disease
- No respiratory illness within the past 2 weeks Patients suspected of or at risk for neoplastic lung disease who are undergoing a bronchoscopy in which differential diagnostic considerations may include multiple other etiologies such as infection and other processes.
- Patients without dysplasia will be: patients undergoing clinically indicated bronchoscopy for conditions other than suspected lung cancer.
- PATIENT CHARACTERISTICS:
- No clinically apparent bleeding diathesis
- No known bleeding disorder
- No anginal
- No clinically active coronary artery disease
- No multifocal premature ventricular contractions
- No poorly controlled congestive heart failure
- No myocardial infarction within the past 6 weeks
- No cardiac dysrhythmia that is potentially life threatening
- Well-controlled atrial fibrillation or rare (\< 2/min) premature ventricular contractions allowed
- No ventricular tachycardia or supraventricular tachycardia with a rapid ventricular response
- No other serious medical condition that would preclude a patient from undergoing a bronchoscopy
- No acute bronchitis or pneumonia within the past 8 weeks except when clinically proven as a possible result of lung cancer
- No hypoxemia (i.e., \< 90% saturation with supplemental oxygen) before bronchoscopy
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Interventions
OTHERimmunohistochemistry staining method
Laboratory test
OTHERlaboratory biomarker analysis
Laboratory Test
OTHERsputum cytology
Laboratory Test
PROCEDUREbiopsy
Laboratory Test
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT00900419
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