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Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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DISEASE CHARACTERISTICS:
- - 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.
PATIENT CHARACTERISTICS:- - No hypoxemia (i.e., < 90% saturation with supplemental oxygen) before bronchoscopy.
PRIOR CONCURRENT THERAPY: - See Disease CharacteristicsTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
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The disease, disorder, syndrome, illness, or injury that is being studied.
OBJECTIVES: Primary.
- - Determine intermediate biomarkers of premalignant respiratory epithelial lesions, such
as genetic mutations or altered growth factor expression, in patients with dysplasia of
the respiratory epithelium or lung cancer, head and neck cancer, or aerodigestive tract
cancer.
Secondary.- - Establish a tissue repository of normal and dysplastic respiratory epithelium from
endobronchial forceps and brush biopsy tissue from these patients and from normal
volunteers.
OUTLINE: Patients are stratified according to presence of extensive and severe dysplasia of the respiratory epithelium (yes vs.#46;no). Participants undergo sputum cytology, white-light (with or without fluorescence) bronchoscopy, and endobronchial biopsies. Participants also undergo endobronchial brushings and bronchial secretion collection and possibly bronchoalveolar lavage. Collected samples are processed by hematoxylin, eosin, and immunohistochemical staining and analyzed for specific biomarkers. Unused samples are stored in the tissue bank. PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Site Contact
Clinical Trials Office - University of Colorado Cancer Center
[email protected]
303-724-1657
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