RecruitingNot ApplicableNCT05973656

Role of Acetaldehyde in the Development of Oral Cancer

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

170 participants

Start Date

Jul 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the role of a chemical called acetaldehyde — a byproduct of alcohol breakdown in the body — in the development of oral cancer. Some people, particularly of East Asian descent, have a genetic variant that causes acetaldehyde to build up when they drink alcohol, leading to flushing. This study collects oral samples to understand how acetaldehyde affects the cells in the mouth and whether it may increase cancer risk. **You may be eligible if...** - You are between 21 and 45 years old (for alcohol drinkers) or 18 to 45 years old (for non-drinkers) - You occasionally drink at least 1 alcoholic drink per month (for drinkers) or have not had alcohol in the last 6 months (for non-drinkers) - You fit into one of these categories: a healthy volunteer without the gene variant (not of East Asian descent), a healthy volunteer with the gene variant (East Asian descent with flushing when drinking), or a person with Fanconi anemia - You are a non-smoker (fewer than 100 cigarettes in your lifetime) **You may NOT be eligible if...** - You are pregnant or nursing - You are taking medications that interact with alcohol - You drink more than 21 alcoholic drinks per week - You have a history of alcohol or drug problems - You currently or recently used tobacco, e-cigarettes, or marijuana - You have an active infection (cold, flu, COVID, sinus) - You have a medical condition that could be worsened by alcohol (such as diabetes requiring insulin, ulcers, or heart problems) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

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NCT05973656


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