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

Lung Cancer Clinical Trial

Official title:

Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218179
• Other study ID #: NIDA-13333-1
• Secondary ID: P50DA013333
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: January 19, 2017
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Tobacco Use Disorder

Intervention

Other:
• Non-intervention
Measured total NNAL and PheT as biomarkers of exposure

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Church TR, Anderson KE, Caporaso NE, Geisser MS, Le CT, Zhang Y, Benoit AR, Carmella SG, Hecht SS. A prospectively measured serum biomarker for a tobacco-specific carcinogen and lung cancer in smokers. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):260- — View Citation

Church TR, Haznadar M, Geisser MS, Anderson KE, Caporaso NE, Le C, Abdullah SB, Hecht SS, Oken MM, Van Ness B. Interaction of CYP1B1, cigarette-smoke carcinogen metabolism, and lung cancer risk. Int J Mol Epidemiol Genet. 2010 Aug 5;1(4):295-309. — View Citation

Fang G, Haznadar M, Wang W, Yu H, Steinbach M, Church TR, Oetting WS, Van Ness B, Kumar V. High-order SNP combinations associated with complex diseases: efficient discovery, statistical power and functional interactions. PLoS One. 2012;7(4):e33531. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer		Cumulative incidence