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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00158145
First received: September 8, 2005
Last updated: June 27, 2008
Last verified: June 2008
  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.


Condition Phase
Tobacco Use Disorder
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Longitudinal Study of Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Biospecimen Retention:   Samples Without DNA

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)
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.

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cigarette smokers

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable physical or mental condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158145

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Investigators
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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014