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NCT Number: NCT05973656

Role of Acetaldehyde in the Development of Oral Cancer

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol

Drug

Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).

Biospecimen Collection

Procedure

Undergo saliva, mouthwash, and cheek brush collection

Breath Test

Procedure

Undergo breathalyzer testing

Primary outcomes

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

    Time frame: Prior 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).

Secondary outcomes

  1. Urine will be analyzed to confirm non-smoking status

    Time frame: Prior to alcohol exposure

    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.

  2. Urine will be analyzed to confirm non-smoking status

    Time frame: Up to 6 hours after alcohol exposure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Balbo Silvia, PhD

CONTACT

[email protected]

612-624-4240

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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