Alcohol-Related CarcinomaNCT05973656
Role of Acetaldehyde in the Development of Oral Cancer
A study testing Alcohol, Biospecimen Collection and Breath Test in people with Alcohol-Related Carcinoma and Fanconi Anemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Carcinoma, Fanconi Anemia, Oral Cavity Carcinoma
- What is being tested?
- Alcohol, Biospecimen Collection and Breath Test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Balbo Silvia, PhD, 612-624-4240, balbo006@umn.edu
About this study
Official title: Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
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.
- Being tested
- Alcohol, Biospecimen Collection, Breath Test
- Medical subject headings
- Fanconi Anemia, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Biospecimen CollectionProcedure or surgery
Undergo saliva, mouthwash, and cheek brush collection
Breath TestProcedure or surgery
Undergo breathalyzer testing
| Study group | Role | What they receive |
|---|---|---|
| Group I (alcohol consumption) | Experimental | 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. Receives: Drug: Alcohol; Procedure: Biospecimen Collection; Procedure: Breath Test |
| Group II (biospecimen collection) | Active comparator | Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Secondary outcomes (2)
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.
Measured: Prior to alcohol exposure
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.
Measured: Up to 6 hours after alcohol exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start8 Jul 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973656
- Sponsor's protocol ID
- SPH-2021-29712
- Other IDs
- NCI-2022-09710
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
- ClinicalTrials.gov ID
- NCT05973656
- Acronym / sponsor ID
- SPH-2021-29712
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (alcohol consumption) | Experimental | Drug: Alcohol, Procedure: Biospecimen Collection, Procedure: Breath TestParticipants 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. |
| Group II (biospecimen collection) | Active comparator | Procedure: Biospecimen Collection, Procedure: Breath TestParticipants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholAlcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC). | Drug | Group I (alcohol consumption) |
| Biospecimen CollectionUndergo saliva, mouthwash, and cheek brush collection | Procedure or surgery | Group I (alcohol consumption), Group II (biospecimen collection) |
| Breath TestUndergo breathalyzer testing | Procedure or surgery | Group I (alcohol consumption), Group II (biospecimen collection) |
Primary outcome
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
Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).
2 secondary outcomes
Urine will be analyzed to confirm non-smoking status
Time frame: Prior to alcohol exposure
Urine will be analyzed to confirm non-smoking status
Time frame: Up to 6 hours after alcohol exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol, Biospecimen Collection and Breath Test in people with Alcohol-Related Carcinoma and Fanconi Anemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Balbo Silvia, PhD (612-624-4240, balbo006@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.