Status:
RECRUITING
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Head and Neck Cancer
Eligibility:
All Genders
21-90 years
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine intermediate biomarkers of premalignant respiratory epithelial lesions, such as genetic mutations or altered growth factor expression, in patients with dysplasia of t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
May 3 2001
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00900419
Start Date
May 3 2001
End Date
September 30 2027
Last Update
September 22 2025
Active Locations (1)
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1
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045