Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT05973656

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

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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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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Role of Acetaldehyde in the Development of Oral Cancer | DecenTrialz