NCT00897364

Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers

Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.

Detailed description

OBJECTIVES: Primary * Define the molecular and biochemical profiles of airway epithelium of smokers with no disease, smokers with airflow obstruction and abnormal sputum cytology, and non-smokers. Secondary * Assess the occurrence of abnormalities in non-smokers, smokers with no disease, smokers with various grades of dysplasia, and smokers with lung cancer. OUTLINE: Patients are stratified according to smoking status (smoker vs non-smoker) and disease (no disease vs airflow obstruction and abnormal sputum cytology vs various grades of dysplasia vs lung cancer). Biological samples are collected and analyzed for future research studies. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.

Conditions

• Lung Cancer
• Precancerous Condition

Timeline

• Start date: 2000-05-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-05-12
• Last updated: 2020-05-15

Locations

1 site across 1 country: United States