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Completed

NCT Number: NCT03285893

Oral Cell DNA Adducts in Smokers

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tobacco Use Research Center

Minneapolis, Minnesota, 55455, United States

About this study

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.

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

oral cell DNA adducts

Other

oral cells will be collected, DNA isolated, and analyzed for adducts

Primary outcomes

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

    Time frame: 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 outcomes

  1. εdAdo, Per 10^9 Nucleotides

    Time frame: Baseline

    Lipid peroxidation-related adduct 1,N6-etheno-dAdo etheno-DNA adducts from peroxidation of lipids. Model adjusted for age, sex and race/ethnicity

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • University of Hawaii

Registry information

Official study title

Quantitation of Oral Cell DNA Adducts in Smokers

Acronym: OCDNA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2017
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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