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Can a single drink reveal how alcohol triggers oral cancer?

NCT ID NCT05973656

Knowledge-focused Sponsor: Masonic Cancer Center, University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study investigates how acetaldehyde, a byproduct of alcohol, affects cells in the mouth and whether it may increase oral cancer risk. Healthy volunteers and individuals with Fanconi anemia (a condition linked to higher cancer risk) will consume a single dose of alcohol and provide saliva, mouthwash, cheek cell, and urine samples. Researchers will measure DNA damage in oral cells to understand the early steps of alcohol-related oral cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a single oral dose of alcohol to reach 0.03% blood alcohol concentration
What this could lead to
If successful, this could clarify how alcohol consumption contributes to oral cancer, potentially guiding prevention strategies.
What could go wrong
This is an early-stage observational study with a small alcohol dose, so findings may not reflect real-world drinking patterns or directly lead to clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Fanconi anemia Mouth Neoplasms oral cavity carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol-related carcinoma Fanconi anemia Oral cavity carcinoma

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Masonic Cancer Center, University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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