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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Tobacco Use Disorder

Study type

Observational

Funder types

NIH

Identifiers

NCT00158145
P50-13333-2
NIDA-13333-2
DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

55 to 74 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Currently smokes
  • Intends to continue smoking for the 12 months following enrollment

Exclusion criteria

  • Unstable physical or mental condition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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