Role of Acetaldehyde in the Development of Oral Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Alcohol
DrugAlcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Biospecimen Collection
Procedure/SurgeryUndergo saliva, mouthwash, and cheek brush collection
Breath Test
Procedure/SurgeryUndergo breathalyzer testing
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Group I (alcohol consumption)Experimental treatment 3 interventions
Group B: Group II (biospecimen collection)Active comparator 2 interventions
Trial outcomes
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).
Time frame
Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol doseSecondary outcomes
1
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.
Time frame
Prior to alcohol exposure2
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.
Time frame
Up to 6 hours after alcohol exposureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Masonic Cancer Center, University of Minnesota
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov