Recruiting

Observational Study

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT05973656

Conditions

Alcohol-Related Carcinoma

Fanconi Anemia

Oral Cavity Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Alcohol

Biospecimen Collection

Breath Test

Study Details

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

Study ID

NCT05973656

Start date

Jul 8, 2022

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Enrollment

170 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

active comparator: Group II (biospecimen collection)

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

Interventions

Alcohol

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

Biospecimen Collection

Undergo saliva, mouthwash, and cheek brush collection

Breath Test

Undergo breathalyzer testing

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Balbo Silvia, PhD

612-624-4240balbo006@umn.edu

Locations

Masonic Cancer Center, University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Balbo Silvia, PhD

612-624-4240balbo006@umn.edu

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2026-07-22.