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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA138338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Hawaii | OTHER |
| National Cancer Institute (NCI) | NIH |
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The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups.
In this 10 day clinical trial, Japanese Americans will smoke a cigarette containing deuterium-labeled 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a tobacco-specific lung carcinogen. The study cigarette will be smoked for 7 days.
This will allow for NNK metabolic profiling and determining the effect of CYP2A6 genotype on the level of NNK α-hydroxylation in Japanese Americans smokers using [pyridine- D4]-NNK containing cigarettes.
Eligible subjects will provide a baseline 24 hour urine sample. Study cigarettes spiked with labeled NNK will be provided to the subjects to smoke over a 7 day period. During this time, 24 hour urine samples will be collected over days 5, 6 and 7 on study cigarettes. Blood will be drawn on days 6 and 7 on study cigarettes. Samples will be analyzed for NNK metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokers with very low or no CYP2A6 activity | Japanese American smokers (daily > 5 cigarettes) with little or no CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of <0.6). |
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| Smokers with high CYP2A6 activity | Japanese American smokers (daily > 5 cigarettes) with high CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of > 3.0) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK | Combination Product | American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
| Measure | Description | Time Frame |
|---|---|---|
| The Ratio of D4-hydroxy Acid to D4- NNAL (an Estimate if NNK Alpha Hydroxylation) | Difference in means of the ratio of D4-hydroxy acid to D4- NNAL (an estimate if NNK alpha hydroxylation) for the two groups (null versus average CYP2A6 activity) | 7 days |
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Inclusion Criteria:
Japanese American - one, but preferably 2 biological parents of Japanese descent
21 years or older
Daily smoker
Eligible urinary ratios of total 3-hydroxycotinine to cotinine (3HC/COT):
Stable and good physical and mental health
Provided written informed consent to participate in the study
Exclusion Criteria:
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Japanese American Smokers
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy K Hatsukami, Ph.D | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
Data will be available in two formats: Summary of the data (graphs and tables) and as raw individual-level data for analysis. Requests for data must be in writing, identify the affiliation and describe how the data will be used. Users agree not to transfer the data to other users and that the data are only to be used for research purposes. The PI will require requestors of data to sign a data and biospecimen sharing agreement that will ensure (1) Use of only for research purposes and not to identify any individual or personal information, (2) Data will be secure, (3) Destruction or return of data after data analysis and (4) Proper citation in publications or other written materials. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
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Data will be available after papers are accepted for publication
Data generated by this grant will be made to outside investigators, according to the Guidance at http://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Smokers With Very Low or no CYP2A6 Activity | Japanese American smokers (daily > 5 cigarettes) with little or no CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of <0.6). Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
| FG001 | Smokers With High CYP2A6 Activity | Japanese American smokers (daily > 5 cigarettes) with high CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of > 3.0) Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smokers With Very Low or no CYP2A6 Activity | Japanese American smokers (daily > 5 cigarettes) with little or no CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of <0.6). Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Ratio of D4-hydroxy Acid to D4- NNAL (an Estimate if NNK Alpha Hydroxylation) | Difference in means of the ratio of D4-hydroxy acid to D4- NNAL (an estimate if NNK alpha hydroxylation) for the two groups (null versus average CYP2A6 activity) | Posted | Mean | Standard Deviation | Ratio | 7 days |
|
1 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smokers With Very Low or no CYP2A6 Activity | Japanese American smokers (daily > 5 cigarettes) with little or no CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of <0.6). Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Murphy, PhD | Masonic Cancer Center | 612-624-7633 | murph062@umn.edu |
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| 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 | Oct 11, 2019 | Apr 15, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2020 | Apr 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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24 hour urine and blood samples
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| BG001 | Smokers With High CYP2A6 Activity | Japanese American smokers (daily > 5 cigarettes) with high CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of > 3.0) Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Smokers With High CYP2A6 Activity |
Japanese American smokers (daily > 5 cigarettes) with high CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of > 3.0) Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Smokers With High CYP2A6 Activity | Japanese American smokers (daily > 5 cigarettes) with high CYP2A6 activity (CYP2A6 activity defined as a ratio of trans-3-hydroxycotinine:cotinine ratio of > 3.0) Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK: American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco. | 0 | 8 | 0 | 8 | 0 | 8 |
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