Oral Cell DNA Adducts in Smokers

NCT ID: NCT03285893

Last Updated: 2024-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Native Hawaiian cigarette smokers

oral cell DNA adducts

oral cell DNA adducts

Intervention Type OTHER

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

White (European Americans) cigarette smokers

oral cell DNA adducts

oral cell DNA adducts

Intervention Type OTHER

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

Japanese American cigarette smokers

oral cell DNA adducts

oral cell DNA adducts

Intervention Type OTHER

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

Interventions

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oral cell DNA adducts

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hawaii

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stepehn Hecht, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Tobacco Use Research Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2017NTLS019

Identifier Type: -

Identifier Source: org_study_id

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