Role of Acetaldehyde in the Development of Oral Cancer

Fanconi Anemia Clinical Trial

Official title:

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973656
• Other study ID #: SPH-2021-29712
• Secondary ID: NCI-2022-09710
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: August 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Balbo Silvia, PhD
• Phone: 612-624-4240
• Email: balbo006[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 30, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Fanconi Anemia
• Fanconi Syndrome
• Oral Cavity Carcinoma

Intervention

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
• Breath Test
Undergo breathalyzer testing

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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