Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

Study Overview
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Brief Summary
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The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.

Official Title
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Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Urine Sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One of the three targeted ethnic groups: Japanese American - two parents of Japanese descent Non-Hispanic Whites - two parents of non-Hispanic white descent Native Hawaiians will include individuals with at least one parent of Hawaiian descent; Smoke 5 cigarettes per day over the past three months; >21 years of age; Consumes 14 or fewer drinks of alcohol per week; Generally stable and good health (determined by review of medical history); Able to provide written voluntary consent before performance of any study related procedure. Exclusion Criteria: Current use of other nicotine containing products for > 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits); Acute or uncontrolled medical or psychiatric conditions; Currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis); Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit; Pregnant or nursing or planning on becoming pregnant during the study; Unable to read and understand English.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Japanese American<br>Two parents of Japanese descent | Diagnostic Test: Urine Sample<br>* One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine<br>|
| Non-Hispanic Whites<br>Two parents of non-Hispanic white descent | Diagnostic Test: Urine Sample<br>* One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine<br>|
| Native Hawaiians<br>At least one parent of Hawaiian descent | Diagnostic Test: Urine Sample<br>* One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Butadiene-DNA adducts in different ethnic groups | Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups. | Day 1 & 2 | 
| Butadiene-DNA adduct load in smokers with lung cancer | Investigate the association between butadiene-DNA adduct load and lung cancer development in smokers. | Day 1 & 2 | 
| Polymorphisms of carnicogen metabolizing genes | Examine how polymorphisms of carcinogen metabolizing genes influence metabolic inactivation, DNA adduct formation/repair, and toxicity of butadiene-derived epoxides. | Day 1 & 2 |