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CompletedNCT00158145Updated Jan 10, 2017

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

An observational study in Tobacco Use Disorder, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 55 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-10.

Sponsored by National Institute on Drug Abuse (NIDA) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
72
Ages
55 Years to 74 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Tobacco Use Disorder

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In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 72 is below the median of 128 across 74 observational studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cigarette smokers

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unstable physical or mental condition
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Study design

Time perspective
Prospective
Enrollment
72 participants (actual)
Biospecimen retention
Samples without dna
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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00158145
Lead sponsor
National Institute on Drug Abuse (NIDA)
First posted
Sep 12, 2005
Start date
Sep 2005
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Jan 10, 2017

Study contacts

Dorothy Hatsukami, Ph.D.
principal investigator · University of Minnesota
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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