Oral Cell DNA Adducts in Smokers

Completed

• Conditions: Lung Cancer
• Interventions: Other: oral cell DNA adducts

• Registration Number: NCT03285893
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

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.

2. 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.

Study Timeline

• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2018-02-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Results First Submitted: 2023-12-07
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Results First Posted: 2024-11-11
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Native Hawaiian cigarette smokers	oral cell DNA adducts	oral cell DNA adducts
White (European Americans) cigarette smokers	oral cell DNA adducts	oral cell DNA adducts
Japanese American cigarette smokers	oral cell DNA adducts	oral cell DNA adducts

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
εdAdo, Per 10^9 Nucleotides	Baseline	Lipid peroxidation-related adduct 1,N6-etheno-dAdo etheno-DNA adducts from peroxidation of lipids. Model adjusted for age, sex and race/ethnicity

Trial Locations

Locations (1)

Tobacco Use Research Center; 🇺🇸 Minneapolis, Minnesota, United States