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

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ClinicalTrials.gov Identifier: NCT00218179
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date September 16, 2005
First Posted Date September 22, 2005
Last Update Posted Date January 23, 2017
Study Start Date September 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2009)
Lung cancer [ Time Frame: Cumulative incidence ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00218179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1
Official Title Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial
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 link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Tobacco Use Disorder
  • Lung Cancer
Intervention Other: Non-intervention
Measured total NNAL and PheT as biomarkers of exposure
Other Name: NNAL-glucuronide, phenanthrene tetraol
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2009)
200
Original Enrollment
 (submitted: September 16, 2005)
0
Actual Study Completion Date December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00218179
Other Study ID Numbers NIDA-13333-1
P50DA013333 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Timothy Church, Ph.D. University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date January 2017