Role of Acetaldehyde in the Development of Oral Cancer

This study is looking at how a substance called acetaldehyde, which is produced when you drink alcohol, might be involved in developing oral (mouth) cancer. We want to see how much acetaldehyde is in your mouth after you drink a small amount of alcohol. You would drink a single dose of alcohol that results in a 0.03% blood alcohol concentration (BAC). Researchers will then collect saliva, mouthwash, and cheek brush samples at different times to measure acetaldehyde levels. This study is for healthy volunteers and people with Fanconi anemia, aged 18 to 45, who occasionally drink alcohol. The study status is currently unclear, and it plans to enroll 170 participants.

Study design: This is an interventional study involving 170 planned participants, including healthy volunteers and individuals with Fanconi anemia.
What's involved: You would consume a single dose of alcohol and provide saliva, mouthwash, and cheek brush samples at various times over 6 hours. You would also undergo breathalyzer testing.
Compensation: Not stated in the trial record.
Follow-up: Acetaldehyde levels will be measured for up to 6 hours after the alcohol dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Role of Acetaldehyde in the Development of Oral Cancer

Recruiting

NAAges 18–45InterventionalBasic science

Masonic Cancer Center, University of Minnesota

~170 participants

Updated 2026-07-22 on ClinicalTrials.gov

What's tested:AlcoholBiospecimen CollectionBreath Test

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose

Measured over Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose

Conditions

Alcohol-Related Carcinoma

Fanconi Anemia

Oral Cavity Carcinoma

Where it's being run

1 sites across 1 states

Minnesota1

Who to contact

Balbo Silvia, PhD

[email protected]

612-624-4240

Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dosePrior 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).

Trialytics