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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Tobacco Use Disorder
Lung Cancer

Treatments

Other: Non-intervention

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00218179
P50DA013333 (U.S. NIH Grant/Contract)
NIDA-13333-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

55 to 74 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Cases
Description:
Lung cancer cases diagnosed prior to 2007 among baseline smokers in the PLCO
Treatment:
Other: Non-intervention
Controls
Description:
Subjects without lung cancer among smokers at baseline in the PLCO study
Treatment:
Other: Non-intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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