Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
|ClinicalTrials.gov Identifier: NCT00897364|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : August 31, 2017
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.
|Condition or disease|
|Lung Cancer Precancerous Condition|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||78 participants|
|Official Title:||Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls|
|Study Start Date :||May 2000|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
- Molecular and biochemical profiles [ Time Frame: Upon completion of trial ]Evaluation of both Molecular and Biochemical profiles of normal non-smokers, smokers with no apparent disease (no airflow obstruction or cancer), and smokers with airflow obstruction and abnormal sputum cytology.
- Occurrence of abnormalities [ Time Frame: Upon completion of trial ]Stratify abnormalities as to whether they occur frequently in normal non-smokers, smokers without disease, smokers with various grades of dysplasia, or smokers with lung cancer.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|