NCT05973656 Role of Acetaldehyde in the Development of Oral Cancer
| NCT ID | NCT05973656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Alcohol-Related Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2022-07-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2022-07-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05973656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Alcohol-Related Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05973656 currently recruiting?
Yes, NCT05973656 is actively recruiting participants. Contact the research team at balbo006@umn.edu for enrollment information.
Where is the NCT05973656 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05973656 clinical trial?
NCT05973656 is sponsored by Masonic Cancer Center, University of Minnesota. The trial plans to enroll 170 participants.