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Trial Title:
Role of Acetaldehyde in the Development of Oral Cancer
NCT ID:
NCT05973656
Condition:
Alcohol-Related Carcinoma
Fanconi Anemia
Oral Cavity Carcinoma
Conditions: Official terms:
Carcinoma
Fanconi Syndrome
Fanconi Anemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Alcohol
Description:
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Arm group label:
Group I (alcohol consumption)
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo saliva, mouthwash, and cheek brush collection
Arm group label:
Group I (alcohol consumption)
Arm group label:
Group II (biospecimen collection)
Intervention type:
Procedure
Intervention name:
Breath Test
Description:
Undergo breathalyzer testing
Arm group label:
Group I (alcohol consumption)
Arm group label:
Group II (biospecimen collection)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Masonic Cancer Center, University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Balbo Silvia, PhD
Phone:
612-624-4240
Email:
balbo006@umn.edu
Start date:
July 8, 2022
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Masonic Cancer Center, University of Minnesota
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Masonic Cancer Center, University of Minnesota
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05973656
