Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Hawaii | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Native Hawaiian cigarette smokers | oral cell DNA adducts |
| |
| White (European Americans) cigarette smokers | oral cell DNA adducts |
| |
| Japanese American cigarette smokers | oral cell DNA adducts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral cell DNA adducts | Other | oral cells will be collected, DNA isolated, and analyzed for adducts |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
100 each of three ethnic groups: Native Hawaiians, Japanese Americans, whites
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stepehn Hecht, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobacco Use Research Center | Minneapolis | Minnesota | 55455 | United States |
Only unidentified data will be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Native Hawaiian Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
| FG001 | White (European Americans) Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
| FG002 | Japanese American Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Native Hawaiian Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
| BG001 | White (European Americans) Cigarette Smokers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Inter-Quartile Range | 10^9 nucleotides/mL | Baseline |
|
Not provided
No adverse events collected, single visit observational study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Native Hawaiian Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joni Jensen | University of Minnesota | 612-624-5178 | jense010@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2020 | Dec 7, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2020 | Dec 7, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
oral cell DNA and urine
oral cell DNA adducts
oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts
| BG002 | Japanese American Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 |
| Japanese American Cigarette Smokers |
oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts |
|
|
| 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 | Posted | Mean | Inter-Quartile Range | 10^9 nucleotides/mL | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | White (European Americans) Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Japanese American Cigarette Smokers | oral cell DNA adducts oral cell DNA adducts: oral cells will be collected, DNA isolated, and analyzed for adducts | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |