Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
研究概览
简要总结
This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples (5 mL each) will be optional and banked for future use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-45 years of age for alcohol drinkers
- •Occasionally consume alcohol
- •At least 1 drink per month for healthy volunteers
- •At least 1 drink in the last 3 months for Fanconi anemia patients
- •Meets one of the three criteria
- •Healthy volunteer - ALDH2*1/1* homozygotes-not of Eastern Asian decent;
- •Healthy volunteer - ALDH2*1/2* heterozygotes-of Eastern Asian decent and experience flushing when drinking
- •Individual's with Fanconi anemia (FA).
- •18-45 years of age for non-drinkers
- •Never consume alcohol/not had alcohol in the last 6 months
- •Healthy volunteers.
- •Non-smoker (smoked < 100 cigarettes in a lifetime)
排除标准
- •Pregnant or nursing
- •Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption
- •Healthy volunteers who have taken any antibiotics in the last 3 months
- •Currently consuming more than 21 drinks per week
- •Have any history of alcohol or drug related problems
- •Current or former tobacco/nicotine product(s) user
- •Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)
- •"Trying" or limited use of any nicotine products or marijuana in the last 1 month
- •Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission in the study will be delayed pending improved health
- •Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)
- •Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol
研究组 & 干预措施
Group I (alcohol consumption)
Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
干预措施: Alcohol (Drug)
Group I (alcohol consumption)
Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Group I (alcohol consumption)
Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
干预措施: Breath Test (Procedure)
Group II (biospecimen collection)
Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Group II (biospecimen collection)
Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
干预措施: Breath Test (Procedure)
结局指标
主要结局
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
时间窗: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).
次要结局
- Urine will be analyzed to confirm non-smoking status(Up to 6 hours after alcohol exposure)
- Urine will be analyzed to confirm non-smoking status(Prior to alcohol exposure)