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Recruiting NCT05973656

Role of Acetaldehyde in the Development of Oral Cancer

No phase Interventional Alcohol-Related Carcinoma Fanconi Anemia Oral Cavity Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alcohol, Biospecimen Collection, Breath Test.
Who it may be relevant to
Registry conditions: Alcohol-Related Carcinoma, Fanconi Anemia, Oral Cavity Carcinoma. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

Overview

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.

Interventions

  • Drug Alcohol
    Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
  • Procedure Biospecimen Collection
    Undergo saliva, mouthwash, and cheek brush collection
  • Procedure Breath Test
    Undergo breathalyzer testing

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Urine will be analyzed to confirm non-smoking status [Time frame: Prior to alcohol exposure]
  • Urine will be analyzed to confirm non-smoking status [Time frame: Up to 6 hours after alcohol exposure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Masonic Cancer Center, University of Minnesota — Minneapolis

Identifiers

NCT: NCT05973656 · SPH-2021-29712 · NCI-2022-09710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗