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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00158145
Enrollment
72
Registered
2005-09-12
Start date
2005-09-30
Completion date
2007-04-30
Last updated
2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Unstable physical or mental condition

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026