Clinical trial NCT05973656: Role of Acetaldehyde in the Development of Oral Cancer
Official title: Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol-Related Carcinoma
Fanconi Anemia
Oral Cavity Carcinoma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-08-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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

Primary outcomes:
measure: Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
timeFrame: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Secondary outcomes:
measure: Urine will be analyzed to confirm non-smoking status
timeFrame: Prior to alcohol exposure
measure: Urine will be analyzed to confirm non-smoking status
timeFrame: Up to 6 hours after alcohol exposure
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
References: