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Oral Cell DNA Adducts in Smokers

Quantitation of Oral Cell DNA Adducts in Smokers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03285893
Acronym
OCDNA
Enrollment
281
Registered
2017-09-18
Start date
2018-02-01
Completion date
2021-08-01
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

OTHERoral cell DNA adducts

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

Sponsors

University of Hawaii
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA AdductBaselineAcrolein-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

MeasureTime frameDescription
εdAdo, Per 10^9 NucleotidesBaselineLipid peroxidation-related adduct 1,N6-etheno-dAdo etheno-DNA adducts from peroxidation of lipids. Model adjusted for age, sex and race/ethnicity

Countries

United States

Participant flow

Participants by arm

ArmCount
Native Hawaiian Cigarette Smokers
oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
101
White (European Americans) Cigarette Smokers
oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
101
Japanese American Cigarette Smokers
oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
79
Total281

Baseline characteristics

CharacteristicJapanese American Cigarette SmokersTotalNative Hawaiian Cigarette SmokersWhite (European Americans) Cigarette Smokers
Age, Continuous59.2 years
STANDARD_DEVIATION 14.6
50.1 years
STANDARD_DEVIATION 16.1
45.5 years
STANDARD_DEVIATION 17.7
47.5 years
STANDARD_DEVIATION 15.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
79 Participants79 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants101 Participants101 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants101 Participants0 Participants101 Participants
Sex: Female, Male
Female
26 Participants128 Participants53 Participants49 Participants
Sex: Female, Male
Male
53 Participants153 Participants48 Participants52 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

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

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

Time frame: Baseline

ArmMeasureValue (MEAN)
Native Hawaiian Cigarette SmokersConcentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct49.7 10^9 nucleotides/mL
White (European Americans) Cigarette SmokersConcentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct67.1 10^9 nucleotides/mL
Japanese American Cigarette SmokersConcentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct46.5 10^9 nucleotides/mL
Secondary

εdAdo, Per 10^9 Nucleotides

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

Time frame: Baseline

ArmMeasureValue (MEAN)
Native Hawaiian Cigarette SmokersεdAdo, Per 10^9 Nucleotides11.3 10^9 nucleotides/mL
White (European Americans) Cigarette SmokersεdAdo, Per 10^9 Nucleotides11.3 10^9 nucleotides/mL
Japanese American Cigarette SmokersεdAdo, Per 10^9 Nucleotides9.16 10^9 nucleotides/mL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026