Alcohol-Related Carcinoma, Fanconi Anemia, Oral Cavity Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGAlcohol
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
PROCEDUREBiospecimen Collection
Undergo saliva, mouthwash, and cheek brush collection
PROCEDUREBreath Test
Undergo breathalyzer testing
Sponsors
Masonic Cancer Center, University of Minnesota
National Institutes of Health (NIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine will be analyzed to confirm non-smoking status | Prior to alcohol exposure | The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine. |
Countries
United States
Contacts
CONTACTBalbo Silvia, PhD
Outcome results
None listed