Role of Acetaldehyde in the Development of Oral Cancer

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT05973656
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 8, 2022
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group I (alcohol consumption)
    Participants who consume alcohol receive a standard drink or an alcohol dose that will result in a 0.03% BAC PO on study. Participants also undergo collection of saliva and breathalyzer testing throughout the trial.
  • Active Comparator: Group II (biospecimen collection)
    Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.

Primary Outcome Measure

Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose [ Time Frame: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455
Balbo Silvia, PhD
[email protected]
612-624-4240

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By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

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