Investigating Vaped Phenanthrene Biomarkers in Former Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Urinary Ratio of D10PheT/D9PhOH
研究概览
简要总结
Some people who used to smoke cigarettes continue to be at higher risk of developing lung cancer, even years after quitting. This study will look to see if a specific chemical, phenanthrene, is broken down in the lungs of former smokers through more harmful pathways than never-smokers. If former smokers break down chemicals that enter their lungs through more harmful pathways this might be putting them at higher risk for developing lung cancer even though they quit smoking. This information may help find better ways to prevent or treat cancer in the future.
This study is under an IND, but the drug is not being studied; instead, it is being used as a marker for drug metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 21 years of age
- •In good physical & mental health
- •In stable physical & mental health
- •Have tried vaping
- •Former daily cigarette smokers who quit 1-20 year ago
- •Non-smokers who have not used tobacco or nicotine products
排除标准
- •Has any respiratory disease (ex - asthma, COPD, etc...)
- •Has/had high blood pressure
- •Has/had liver disease
- •Has/had cancer
- •Has experience negative effects when vaped previously
- •Pregnant or nursing
研究组 & 干预措施
D10-phenanthrene
All study participants (Former Daily Smokers and Non-smokers) will be asked to vape D10-phenanthrene to see how their lungs breakdown a class of cancer-causing chemicals known as polycyclic aromatic hydrocarbons [PAHs].
干预措施: D10-phenanthrene (Other)
结局指标
主要结局
Urinary Ratio of D10PheT/D9PhOH
时间窗: 24 hours after vaping phenanthrene
The ratio of D10-phenanthrene tetraol to D9-phenanthrene phenols in the urine will determine how the lung breaks down a class of cancer-causing chemicals called Polycyclic Aromatic Hydrocarbons (PAHs). The higher this ratio the more the lungs break down these chemicals through harmful pathways, which might increase cancer risk. The lower the ratio the more the lung breaks down the chemicals through safer pathways.
TNE
时间窗: Baseline measure
Total nicotine equivalents will be measured in the urine samples to confirm that study participants are not using tobacco or nicotine products.
次要结局
未报告次要终点