Fanconi Anemia Clinical Trial
Official title:
Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
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.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | September 30, 2027 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose | Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples). | Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose | |
Secondary | Urine will be analyzed to confirm non-smoking status | 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. | Prior to alcohol exposure | |
Secondary | Urine will be analyzed to confirm non-smoking status | 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. | Up to 6 hours after alcohol exposure |
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