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Role of Acetaldehyde in the Development of Oral Cancer

NCT05973656 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-08-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2026-11-30
Completion
2027-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973656 on ClinicalTrials.gov