Investigating how acetaldehyde contributes to oral cancer development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention involves healthy volunteers and individuals with Fanconi anemia consuming a single dose of alcohol to study the role of acetaldehyde in oral cancer development. Participants will provide non-invasive biological samples, including saliva, oral cells, and urine, at various time points. Optional blood samples will also be collected for future research. The study aims to understand the biological effects of alcohol consumption on individuals with different genetic backgrounds related to alcohol metabolism.

Why it matters

Who can join: the full rules

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

Where it's running

• Masonic Cancer Center, University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Balbo Silvia, PhD
• Email: balbo006@umn.edu
• Phone: 612-624-4240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.