NCT05973656

Role of Acetaldehyde in the Development of Oral Cancer

Dissecting the Role of Acetaldehyde in Oral Carcinogenesis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol-Related Carcinoma
• Fanconi Anemia
• Oral Cavity Carcinoma

Interventions

Type	Name	Description
DRUG	Alcohol	Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
PROCEDURE	Biospecimen Collection	Undergo saliva, mouthwash, and cheek brush collection
PROCEDURE	Breath Test	Undergo breathalyzer testing

Timeline

• Start date: 2022-07-08
• Primary completion: 2026-11-30
• Completion: 2027-09-30
• First posted: 2023-08-03
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States