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NCT00158145 Clinical Trial

Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2

Tobacco Use Disorder Clinical Trial

Official title:
Longitudinal Study of Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00158145
Other study ID # NIDA-13333-2
Secondary ID P50-13333-2DPMC
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated January 9, 2017
Start date September 2005
Est. completion date April 2007

Study information
Verified date June 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 74 Years
Eligibility Inclusion Criteria:

- Currently smokes

- Intends to continue smoking for the 12 months following enrollment

Exclusion Criteria:

- Unstable physical or mental condition

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

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