Trial Outcomes & Findings for Oral Cell DNA Adducts in Smokers (NCT NCT03285893)

NCT ID: NCT03285893

Last Updated: 2024-11-12

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 281 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-11-12

Participant Flow

Participant milestones

Measure	Native Hawaiian Cigarette Smokers oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	White (European Americans) Cigarette Smokers oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	Japanese American Cigarette Smokers oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
Overall Study STARTED	101	101	79
Overall Study COMPLETED	101	101	79
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Cell DNA Adducts in Smokers

Baseline characteristics by cohort

Measure	Native Hawaiian Cigarette Smokers n=101 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	White (European Americans) Cigarette Smokers n=101 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	Japanese American Cigarette Smokers n=79 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	Total n=281 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 17.7 • n=5 Participants	47.5 years STANDARD_DEVIATION 15.7 • n=7 Participants	59.2 years STANDARD_DEVIATION 14.6 • n=5 Participants	50.1 years STANDARD_DEVIATION 16.1 • n=4 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	49 Participants n=7 Participants	26 Participants n=5 Participants	128 Participants n=4 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	52 Participants n=7 Participants	53 Participants n=5 Participants	153 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	79 Participants n=5 Participants	79 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	101 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	101 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	101 Participants n=7 Participants	0 Participants n=5 Participants	101 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Native Hawaiian Cigarette Smokers n=101 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	White (European Americans) Cigarette Smokers n=101 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	Japanese American Cigarette Smokers n=79 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct	49.7 10^9 nucleotides/mL Interval 41.2 to 59.9	67.1 10^9 nucleotides/mL Interval 55.7 to 80.7	46.5 10^9 nucleotides/mL Interval 37.2 to 58.0

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Native Hawaiian Cigarette Smokers n=101 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	White (European Americans) Cigarette Smokers n=101 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts	Japanese American Cigarette Smokers n=79 Participants oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
εdAdo, Per 10^9 Nucleotides	11.3 10^9 nucleotides/mL Interval 9.9 to 12.9	11.3 10^9 nucleotides/mL Interval 9.94 to 12.9	9.16 10^9 nucleotides/mL Interval 7.83 to 10.7

Adverse Events

Native Hawaiian Cigarette Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

White (European Americans) Cigarette Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Japanese American Cigarette Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joni Jensen

University of Minnesota

Phone: 612-624-5178

Email: jense010@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place