Text Size

Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218179
First received: September 16, 2005
Last updated: April 23, 2009
Last verified: April 2009
History of Changes
  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 link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.


Condition Intervention
Tobacco Use Disorder
 Other: Non-intervention

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Lung cancer [ Time Frame: Cumulative incidence ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cases
Lung cancer cases diagnosed prior to 2007 among baseline smokers in the PLCO
 Other: Non-intervention
Measured total NNAL and PheT as biomarkers of exposure
Other Name: NNAL-glucuronide, phenanthrene tetraol
Controls
Subjects without lung cancer among smokers at baseline in the PLCO study
 Other: Non-intervention
Measured total NNAL and PheT as biomarkers of exposure
Other Name: NNAL-glucuronide, phenanthrene tetraol

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 link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.

This observational case-control study will involve a random selection from a group of smokers who are participating in the Prostrate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial. The chosen cases will include 300 incident lung cancer cases and 300 controls (participants who have had no diagnosis of lung cancer). Demographic and baseline data from the PLCO database will be obtained. Prior baseline blood samples from the PLCO trial will be obtained as well. Based on age, sex, and smoking history, participants will be grouped into triplets in order to pool their blood samples. These samples will then be analyzed to determine whether distributions of biomarker levels in lung cancer participants differ from those in non-lung cancer participants. This study will not involve recruitment of any participants, as data and samples from the PLCO trial will be used and no new blood samples will be obtained.

  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

Case-control study nested within the Prostate Lung Colorectal and Ovarian Cancer Screening Trial. Subjects consisted of screening arm subjects who were smokers at baseline and who contributed biorepository samples at the first screening visit.

Criteria

Inclusion Criteria:

  • Screening arm participants in the Prostate, Lung, Colon, and Ovarian Screen Trial (PLCO)
  • Reported smoking on baseline questionnaire of PLCO
  • Contributed biorepository samples

Exclusion Criteria:

  • Unstable physical or mental health
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218179

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Timothy R. Church, PhD, University of Minnesota
ClinicalTrials.gov Identifier: NCT00218179     History of Changes
Other Study ID Numbers: NIDA-13333-1, P50-13333-1, DPMC
Study First Received: September 16, 2005
Last Updated: April 23, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013