ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment
Tobacco Use Disorder Lung Cancer Other: Non-intervention

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
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial
Study Start Date : September 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Lung cancer [ Time Frame: Cumulative incidence ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218179


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

Publications of Results:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00218179     History of Changes
Other Study ID Numbers: NIDA-13333-1
P50DA013333 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Lung Cancer
Cotinine
NNAL
Carcinogens
Case-control
SNPs

Additional relevant MeSH terms:
Lung Neoplasms
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders