Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer - Head and Neck Cancer - Lung Cancer - Precancerous Condition
Conditions: official terms
Esophageal Neoplasms - Head and Neck Neoplasms - Lung Neoplasms - Precancerous Conditions
Conditions: Keywords
non-small cell lung cancer, small cell lung cancer, squamous lung dysplasia, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, metastatic squamous neck cancer with occult primary, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, salivary gland cancer, esophageal cancer, pulmonary carcinoid tumor, tongue cancer
Study Type
Study Phase
Phase 2
Study Design
Time Perspective: Prospective
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Name: sputum cytology Type: Other
Name: biopsy Type: Procedure
Overall Status
RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer and from normal volunteers 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 and in normal volunteers.
Detailed Description


- 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.


- 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 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 90 Years
Minimum Age: 21 Years
Gender: Both

- Meets any of the following criteria:

- Diagnosis of extensive and severe 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 dysplasia (normal volunteers)

- 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.


- 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


- See Disease Characteristics
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Status: Recruiting
Contact: Clinical Trials Office - University of Colorado Cancer Center - 303-724-1650
Start Date
March 2002
Completion Date
May 2018
University of Colorado, Denver
University of Colorado, Denver
Record processing date processed this data on July 28, 2015 page