NCT00900419

Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers

Biomarkers and Dysplastic Respiratory Epithelium

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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 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 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.

Conditions

• Esophageal Cancer
• Head and Neck Cancer
• Lung Cancer
• Precancerous Condition

Interventions

Type	Name	Description
OTHER	immunohistochemistry staining method	Laboratory test
OTHER	laboratory biomarker analysis	Laboratory Test
OTHER	sputum cytology	Laboratory Test
PROCEDURE	biopsy	Laboratory Test

Timeline

• Start date: 2001-05-03
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2009-05-12
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States