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Role of Acetaldehyde in the Development of Oral Cancer

Primary Purpose

Alcohol-Related Carcinoma, Fanconi Anemia, Oral Cavity Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Biospecimen Collection
Breath Test
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol-Related Carcinoma

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Masonic Cancer Center, University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (alcohol consumption)

Group II (biospecimen collection)

Arm Description

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.

Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.

Outcomes

Primary Outcome Measures

Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).

Secondary Outcome Measures

Urine will be analyzed to confirm non-smoking status
The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.
Urine will be analyzed to confirm non-smoking status
The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.

Full Information

First Posted
July 17, 2023
Last Updated
August 16, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05973656
Brief Title
Role of Acetaldehyde in the Development of Oral Cancer
Official Title
Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Carcinoma, Fanconi Anemia, Oral Cavity Carcinoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (alcohol consumption)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (biospecimen collection)
Arm Type
Active Comparator
Arm Description
Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo saliva, mouthwash, and cheek brush collection
Intervention Type
Procedure
Intervention Name(s)
Breath Test
Intervention Description
Undergo breathalyzer testing
Primary Outcome Measure Information:
Title
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
Description
Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).
Time Frame
Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Secondary Outcome Measure Information:
Title
Urine will be analyzed to confirm non-smoking status
Description
The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.
Time Frame
Prior to alcohol exposure
Title
Urine will be analyzed to confirm non-smoking status
Description
The optional blood samples will be analyzed for DNA adducts in the blood. We will measure the total concentration of the marker NNAL in urine.
Time Frame
Up to 6 hours after alcohol exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balbo Silvia, PhD
Phone
612-624-4240
Email
balbo006@umn.edu
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balbo Silvia, PhD
Phone
612-624-4240
Email
balbo006@umn.edu

12. IPD Sharing Statement

Learn more about this trial

Role of Acetaldehyde in the Development of Oral Cancer

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