Role of Acetaldehyde in the Development of Oral Cancer (NCT05973656) | Clinical Trial Compass
RecruitingNot Applicable
Role of Acetaldehyde in the Development of Oral Cancer
United States170 participantsStarted 2022-07-08
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
Timeframe: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Trial details
NCT IDNCT05973656
SponsorMasonic Cancer Center, University of Minnesota