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Recruiting
NCT00900419
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Conditions: Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Precancerous Condition
Sex: All
Ages: 21 Years – 90 Years
Healthy volunteers: No
Enrollment: 700
Sponsor: University of Colorado, Denver
Location: University of Colorado Cancer Center at UC Health Sciences Center Aurora Colorado
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 Criteria
Inclusion Criteria:
Two broad patient groups are of interest: those with extensive and severe dysplasia of the respiratory epithelium and those without dysplasia of the respiratory epithelium. The patients with dysplasia will be recruited from the following:
* Individuals identified through the SPORE Tissue Procurement Screening Project with moderate or severe dysplasia.
* Patients identified by private and academic physicians with moderate or severe dysplasia on cytology.
* One year or greater survivors of one or more aerodigestive system carcinomas.
* Patients with head and neck cancers who are undergoing routine panendoscopy.
* Patients undergoing resection of a bronchogenic carcinoma.
* Fully resected Stage I non-small cell cancer patients.
* Patient's undergoing bronchoscopy for diagnosis or staging of suspected lung cancer.
* Subjects with previous high-grade dysplasia or worse undergoing subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment.
* 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.
Exclusion Criteria:
Patients are not eligible if any one of the following conditions exist:
* Clinically apparent bleeding diathesis.
* Cardiac dysrhythmia that is potentially life threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (\< 2/minute) premature ventricular contractions are not exclusionary.
* Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
* Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, anginal chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.
* Acute bronchitis or pneumonia within 8 weeks, except if these are considered clinically to be possibly a result of lung cancer.
* Inability to give informed consent
Source: ClinicalTrials.gov (NCT00900419). StuddyBuddy aggregates publicly available trial information.