Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
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.
Other: laboratory biomarker analysis
|Study Design:||Time Perspective: Prospective|
|Official Title:||Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls|
- Molecular and biochemical profiles [ Time Frame: Upon completion of trial ] [ Designated as safety issue: No ]
- Occurrence of abnormalities [ Time Frame: Upon completion of trial ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
endobronchial biopsies, blood, sputum, urine
|Study Start Date:||May 2000|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897364
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||York E. Miller, MD||University of Colorado, Denver|