Role of Acetaldehyde in the Development of Oral Cancer

NCT05973656 | Recruiting DMC

• 2 other identifiers: SPH-2021-29712NCI-2022-09710
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-Related Carcinoma; Fanconi Anemia; Oral Cavity Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Urine will be analyzed to confirm non-smoking status

  Prior to alcohol exposure

• Urine will be analyzed to confirm non-smoking status

  Up to 6 hours after alcohol exposure

Study Arms (2)

Group I (alcohol consumption)

EXPERIMENTAL

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; Procedure: Biospecimen Collection; Procedure: Breath Test

Group II (biospecimen collection)

ACTIVE COMPARATOR

Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.

Procedure: Biospecimen Collection; Procedure: Breath Test

Interventions

Alcohol DRUG

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

Group I (alcohol consumption)

Biospecimen Collection PROCEDURE

Undergo saliva, mouthwash, and cheek brush collection

Group I (alcohol consumption); Group II (biospecimen collection)

Breath Test PROCEDURE

Undergo breathalyzer testing

Group I (alcohol consumption); Group II (biospecimen collection)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Fanconi Anemia; Mouth Neoplasms

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Bone Marrow Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Balbo Silvia, PhD

CONTACT

612-624-4240; balbo006@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 3, 2023
• Study Start: July 8, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)