Clinical trial · Observational
Metabolism of NNK Among African Americans
Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking: Project 5: Metabolism of NNK Among African Americans
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Metabolism and DNA adduct formation are critical in cancer induction by NNK. The investigators goal is to understand whether the observed ethnic/racial differences in lung cancer incidence are due to variations in NNK metabolism. The investigators overall hypothesis is that cancer susceptibility relates to carcinogen dose and to the balance between carcinogen metabolic activation and detoxification. The investigators propose to test this hypothesis via investigation of potential differences in NNK metabolic activation and detoxification in African American and European American smokers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- African Americans
- description
- Subjects will be classified as African American if they report themselves, biological parents and both sets of biological grandparents as African American or African descent.
- label
- European American
- description
- Subjects will be classified as European American if they report themselves, biological parents and both sets of biological grandparents as European American or European descent.
Primary outcomes (1)
- measure
- Conduct a comprehensive analysis of urinary biomarkers of NNK metabolic activation and detoxification in African American and European American smokers.
- timeFrame
- 10 days
- description
- We will recruit smokers to smoke specially prepared cigarettes containing \[pyridine-D4\]NNK, and measure deuterium-labeled NNK metabolites in the urine of these subjects. The rationale for the use of deuterium-labeled NNK is that we need to specifically identify NNK-derived metabolites, because these biomarkers are also formed as a result of nicotine metabolism. Our overall hypothesis is that the relative contribution of the biomarkers of NNK metabolic activation to the total amount of NNK metabolites will be higher in African Americans as compared to European Americans.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female subjects with a smoking history of at least 10 cigarettes daily for at least 1 year; 2. Subjects report themselves, biological parents and both sets of biological grandparents as * African American or African descent or * European American or European descent 3. Subjects are in apparently good physical health (no unstable medical condition) 4. Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the PRIME-MD); 5. Subjects have provided written informed consent to participate in the study. Exclusion Criteria: 1. Unstable medical conditions including cancer, coronary heart disease and arrhythmia 2. Cannot or unwilling to identify ethnic/racial ancestry 3. Women who are currently pregnant or breast feeding 4. Currently using any other tobacco or nicotine-containing product 5. Currently taking any medications that affect relevant metabolic enzymes.
References
Publications (0)
Data not yet available