Role of Acetaldehyde in the Development of Oral Cancer

Not Applicable

Recruiting

• Conditions: Fanconi Anemia; Alcohol-Related Carcinoma; Oral Cavity Carcinoma
• Interventions: Procedure: Biospecimen Collection; Drug: Alcohol; Procedure: Breath Test

• Registration Number: NCT05973656
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-11-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (biospecimen collection)	Biospecimen Collection	Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
Group I (alcohol consumption)	Breath Test	Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
Group I (alcohol consumption)	Biospecimen Collection	Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
Group II (biospecimen collection)	Breath Test	Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
Group I (alcohol consumption)	Alcohol	Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.

Primary Outcome Measures

Name	Time	Method
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose	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 Outcome Measures

Name	Time	Method
Urine will be analyzed to confirm non-smoking status	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.

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States