Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2
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Purpose
Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism 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.
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Longitudinal Study of Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial |
Urine and blood samples.
| Enrollment: | 72 |
| Study Start Date: | September 2005 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 55 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Cigarette smokers
Inclusion Criteria:
- Currently smokes
- Intends to continue smoking for the 12 months following enrollment
Exclusion Criteria:
- Unstable physical or mental condition
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Tim Church, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00158145 History of Changes |
| Other Study ID Numbers: | NIDA-13333-2, P50-13333-2, DPMC |
| Study First Received: | September 8, 2005 |
| Last Updated: | June 27, 2008 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013