Actively Recruiting
Role of Acetaldehyde in the Development of Oral Cancer
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-08-22
170
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
Sponsors
M
Masonic Cancer Center, University of Minnesota
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Acetaldehyde in the Development of Oral Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 45 years 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
- Meet one of the following: healthy volunteer ALDH21/1 homozygotes not of Eastern Asian descent, healthy volunteer ALDH21/2 heterozygotes of Eastern Asian descent who experience flushing when drinking, or individuals with Fanconi anemia
- Age 18 to 45 years for non-drinkers
- Never consume alcohol or have not had alcohol in the last 6 months
- Healthy volunteers
- Non-smokers (smoked fewer than 100 cigarettes in a lifetime)
You will not qualify if you...
- Pregnant or nursing
- Taking any medication or drug that might affect alcohol use or absorption or 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
- History of alcohol or drug related problems
- Current or former tobacco or nicotine product user
- Regular use of tobacco, nicotine products, or marijuana in the last year
- Any limited use of nicotine products or marijuana in the last month
- Active infection such as influenza, cold, COVID, or respiratory/sinus infection (admission delayed until improved)
- Non-Fanconi anemia volunteers with unstable medical conditions or conditions affected by alcohol such as insulin-dependent diabetes, ulcers, or heart issues
- Experience severe adverse events like nausea or blacking out when consuming even low doses of alcohol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
B
Balbo Silvia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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