Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2
|ClinicalTrials.gov Identifier: NCT00158145|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 10, 2017
|Condition or disease||Phase|
|Tobacco Use Disorder||Phase 2|
Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.
Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.
This longitudinal observational study will involve a repeated measure analysis of 6 different tobacco carcinogen biomarkers. Fifty current smokers who intend to continue smoking for the duration of the study will be recruited through advertisements. Participants will be compensated for their time. Blood samples will be collected every two months for one year. All samples will be analyzed for the 6 different carcinogen biomarkers and individual variability in biomarker levels will be assessed.
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Official Title:||Longitudinal Study of Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial|
|Study Start Date :||September 2005|
|Primary Completion Date :||April 2007|
|Study Completion Date :||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158145
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Dorothy Hatsukami, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|