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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00218179
First received: September 16, 2005
Last updated: August 25, 2014
Last verified: August 2014

September 16, 2005
August 25, 2014
September 2005
December 2007   (final data collection date for primary outcome measure)
Lung cancer [ Time Frame: Cumulative incidence ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00218179 on ClinicalTrials.gov Archive Site
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Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1
Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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.

  • Tobacco Use Disorder
  • Lung Cancer
Other: Non-intervention
Measured total NNAL and PheT as biomarkers of exposure
Other Name: NNAL-glucuronide, phenanthrene tetraol
  • Cases
    Lung cancer cases diagnosed prior to 2007 among baseline smokers in the PLCO
    Intervention: Other: Non-intervention
  • Controls
    Subjects without lung cancer among smokers at baseline in the PLCO study
    Intervention: Other: Non-intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
55 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218179
NIDA-13333-1, P50DA013333, N01CN25513
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Timothy Church, Ph.D. University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP