Exploring how Japanese Americans metabolize a tobacco carcinogen
STUDY 2: CLINICAL PROTOCOL Metabolism of NNK Among Japanese Americans
This study is testing how Japanese American smokers process a harmful chemical in tobacco to see if their genetics affect their risk of lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT04228952 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the metabolism of a tobacco-specific lung carcinogen, NNK, among Japanese American smokers. Participants will smoke specially prepared cigarettes containing deuterium-labeled NNK for seven days, during which urine and blood samples will be collected to analyze NNK metabolic profiling. The study aims to understand how genetic variations in the CYP2A6 enzyme influence the metabolism of NNK and potentially contribute to lung cancer risk in this population. By examining these metabolic differences, the research seeks to shed light on the varying risks of lung cancer among different ethnic groups.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese American daily smokers aged 21 and older with specific CYP2A6 activity levels.
Not a fit: Patients who do not identify as Japanese American or who do not meet the smoking and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and prevention strategies for lung cancer in Japanese Americans.
How similar studies have performed: While studies on tobacco metabolism exist, this specific focus on Japanese Americans and the use of deuterium-labeled NNK is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Japanese American - one, but preferably 2 biological parents of Japanese descent 2. 21 years or older 3. Daily smoker 4. Eligible urinary ratios of total 3-hydroxycotinine to cotinine (3HC/COT): * "Little or no-CYP2A6 activity" defined as a 3-hydroxycotinine:cotinine ratio of \<0.6 or * "Relatively high" CYP2A6 activity defined as a 3-hydroxycotinine:cotinine ratio of \>3.0. 5. Stable and good physical and mental health 6. Provided written informed consent to participate in the study Exclusion Criteria: 1. Unwilling to avoid other nicotine containing products during the study and no use of any nicotine-containing products except cigarettes for 1 week prior to their study visits 2. Currently taking any medications that affect relevant metabolic enzymes 3. Experiencing medical conditions that might affect biomarkers of exposure and effect 4. Pregnant or nursing or planning on becoming pregnant during the study 5. Unable to read and understand English
Where this trial is running
Honolulu, Hawaii
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Principal investigator: Dorothy K Hatsukami, Ph.D — Masonic Cancer Center, University of Minnesota
- Study coordinator: Joni Jensen, MPH
- Email: jense010@umn.edu
- Phone: 612-624-5178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.