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临床试验/NCT03285893
NCT03285893已完成不适用

Quantitation of Oral Cell DNA Adducts in Smokers

University of Minnesota1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
281
试验地点
1
主要终点
Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct

研究概览

简要总结

DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.

详细描述

Using high resolution mass spectrometry, quantify known DNA adducts in oral mucosa cells of 100 smokers from each ethnic group - Native Hawaiians, Whites, and Japanese Americans. DNA adducts of tobacco-specific compounds, formaldehyde, and acrolein will be quantified.

  1. Analyze the urine of 100 smokers and 100 non-smokers from each of these groups for mercapturic acids of acrolein and crotonaldehyde, as well as total nicotine equivalents and total NNAL (smokers only). These data will provide critical information relevant to the high risk of Native Hawaiians for lung cancer, and in relationship to the DNA adduct measurements of Specific Aim 1.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.

排除标准

  • no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.

结局指标

主要结局

Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct

时间窗: Baseline

Acrolein-DNA adduct (8R/S)-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahy- dro-8-hydroxypyrimido\[1,2-a\]purine-10(3H)-one. Model adjusted for age, sex and race/ethnicity

次要结局

  • εdAdo, Per 10^9 Nucleotides(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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