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临床试验/NCT03421678
NCT03421678撤回不适用

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

Masonic Cancer Center, University of Minnesota0 个研究点开始时间: 2020年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Butadiene-DNA adducts in different ethnic groups

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Butadiene-DNA adducts in different ethnic groups

时间窗: Day 1 & 2

Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups.

Polymorphisms of carnicogen metabolizing genes

时间窗: Day 1 & 2

Examine how polymorphisms of carcinogen metabolizing genes influence metabolic inactivation, DNA adduct formation/repair, and toxicity of butadiene-derived epoxides.

Butadiene-DNA adduct load in smokers with lung cancer

时间窗: Day 1 & 2

Investigate the association between butadiene-DNA adduct load and lung cancer development in smokers.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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