Role of Acetaldehyde in the Development of Oral Cancer

Not Applicable

Recruiting

• Conditions: Alcohol-Related Carcinoma; Fanconi Anemia; Oral Cavity Carcinoma

• Registration Number: NCT05973656
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-7-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - 21-45 years of age for alcohol drinkers<br><br> - Occasionally consume alcohol<br><br> - At least 1 drink per month for healthy volunteers<br><br> - At least 1 drink in the last 3 months for Fanconi anemia patients<br><br> - Meets one of the three criteria<br><br> - Healthy volunteer - ALDH21/1 homozygotes-not of Eastern Asian decent;<br><br> - Healthy volunteer - ALDH21/2 heterozygotes-of Eastern Asian decent and experience<br> flushing when drinking<br><br> - Individual's with Fanconi anemia (FA).<br><br> - 18-45 years of age for non-drinkers<br><br> - Never consume alcohol/not had alcohol in the last 6 months<br><br> - Healthy volunteers.<br><br> - Non-smoker (smoked < 100 cigarettes in a lifetime)<br><br>Exclusion Criteria:<br><br> - Pregnant or nursing<br><br> - Taking any medication or drug that might affect alcohol use and absorption or that<br> might be affected by alcohol consumption<br><br> - Healthy volunteers who have taken any antibiotics in the last 3 months<br><br> - Currently consuming more than 21 drinks per week<br><br> - Have any history of alcohol or drug related problems<br><br> - Current or former tobacco/nicotine product(s) user<br><br> - Any regular use of tobacco/nicotine products or marijuana in the last year<br> (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)<br><br> - Trying or limited use of any nicotine products or marijuana in the last 1 month<br><br> - Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission<br> in the study will be delayed pending improved health<br><br> - Non-FA volunteers who have an unstable medical condition or condition that could be<br> affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)<br><br> - Experience severe adverse events (nausea, blacking out) when consuming even low<br> doses of alcohol

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose

Secondary Outcome Measures

Name	Time	Method
Urine will be analyzed to confirm non-smoking status;Urine will be analyzed to confirm non-smoking status