Status:
RECRUITING
Role of Acetaldehyde in the Development of Oral Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Alcohol-Related Carcinoma
Fanconi Anemia
Eligibility:
All Genders
18-45 years
Phase:
NA
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 va...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05973656
Start Date
July 8 2022
End Date
September 30 2027
Last Update
August 22 2025
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455