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| ID | Type | Description | Link |
|---|---|---|---|
| SPORE 24 | Other Identifier | SPORE Number | |
| P50CA058187 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to presence of extensive and severe dysplasia of the respiratory epithelium (yes vs 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunohistochemistry staining method | Other | Laboratory test | ||
| laboratory biomarker analysis | Other | Laboratory Test | ||
| sputum cytology | Other | Laboratory Test | ||
| biopsy | Procedure | Laboratory Test |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic mutations or altered growth factor expression | After study has completed |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of a tissue repository of normal and dysplastic respiratory epithelium | After study has closed |
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Inclusion Criteria:
Diagnosis of extensive and severe dysplasia of the respiratory epithelium
Those without dysplasia of the respiratory epithelium
Survived 1 or more aerodigestive system carcinoma for ≥ 1 year
Completely resected stage I non-small cell cancer
Undergoing any of the following procedures:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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High Risk for Lung Cancer, suspected lung cancer, lung cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandi Kubala | Contact | 303-724-1657 | brandi.kubala@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| York E. Miller, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center at UC Health Sciences Center | Recruiting | Aurora | Colorado | 80045 | United States |
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Sputum sample, Endobronchial biopsy, bronchial secretions, pulmonary lavage, blood and urine.
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D011230 | Precancerous Conditions |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D012468 | Salivary Gland Neoplasms |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D012466 | Salivary Gland Diseases |
| D014060 | Tongue Diseases |
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| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
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