Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
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• 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)

Locations
United States
Minnesota
Masonic Cancer Center, University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Balbo Silvia, PhD
balbo006@umn.edu
612-624-4240
Time Frame
Start Date: 2022-07-08
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 170
Treatments
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.
Sponsors
Leads: Masonic Cancer Center, University of Minnesota
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov

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