Role of Acetaldehyde in the Development of Oral Cancer

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

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.

Study Overview

• Status: Recruiting
• Conditions: Fanconi Anemia; Oral Cavity Carcinoma; Alcohol-Related Carcinoma
• Intervention / Treatment: Drug: Alcohol; Procedure: Biospecimen Collection; Procedure: Breath Test

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Balbo Silvia, PhD; Phone Number: 612-624-4240; Email: balbo006@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Masonic Cancer Center, University of Minnesota
      • Contact: Balbo Silvia, PhD; Phone Number: 612-624-4240; Email: balbo006@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (alcohol consumption); 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.	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
Active Comparator: Group II (biospecimen collection); Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.	Procedure: Biospecimen Collection; Undergo saliva, mouthwash, and cheek brush collection; Procedure: Breath Test; Undergo breathalyzer testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose	Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).	Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine will be analyzed to confirm non-smoking status	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.	Prior to alcohol exposure
Urine will be analyzed to confirm non-smoking status	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.	Up to 6 hours after alcohol exposure

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Urogenital Diseases; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Metabolic Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Neoplasms, Glandular and Epithelial; Bone Marrow Diseases; Anemia; DNA Repair-Deficiency Disorders; Renal Tubular Transport, Inborn Errors; Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Carcinoma; Fanconi Syndrome; Fanconi Anemia
• Other Study ID Numbers: SPH-2021-29712; NCI-2022-09710 (Registry Identifier: NCI Trial ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No