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Alcohol Exposure for Oral Cancer Risk
N/A
Recruiting
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Awards & highlights
Study Summary
This trial studies the effects of a single dose of alcohol on healthy volunteers and those with Fanconi anemia. Biological samples like saliva, cells, and urine will be taken, with optional blood samples.
Who is the study for?
This trial is for healthy volunteers and individuals with Fanconi anemia who occasionally drink alcohol. Participants should be non-smokers, aged 18-45 (21-45 for drinkers), and not have used antibiotics or experienced severe reactions to alcohol recently. Pregnant or nursing individuals, heavy drinkers, those with unstable health conditions affected by alcohol, or recent tobacco/nicotine users are excluded.Check my eligibility
What is being tested?
The study investigates how acetaldehyde contributes to oral cancer development after consuming a single dose of alcohol. It involves collecting saliva, mouthwash cells, cheek brush cells, urine samples from participants at different times post-consumption. Blood sample collection is optional.See study design
What are the potential side effects?
Since this is a minimal risk intervention involving the consumption of a single dose of alcohol and sample collection, side effects may include typical reactions to alcohol such as mild discomfort or intoxication symptoms depending on individual tolerance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose
Secondary outcome measures
Urine will be analyzed to confirm non-smoking status
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (alcohol consumption)Experimental Treatment3 Interventions
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.
Group II: Group II (biospecimen collection)Active Control2 Interventions
Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Alcohol
2008
Completed Phase 3
~2000
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,483 Total Patients Enrolled
6 Trials studying Fanconi Anemia
235 Patients Enrolled for Fanconi Anemia
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,680 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently drinking more than 21 drinks per week.You drink alcohol at least once a month.I currently do not have any active infections like the flu, cold, or COVID.You have consumed at least one alcoholic drink in the past three months and have Fanconi anemia.I am either a healthy volunteer with specific genetic traits, of Eastern Asian descent with alcohol flushing, or have Fanconi anemia.I am between 18 and 45 years old and do not drink alcohol.You drink alcohol sometimes.I am healthy but have taken antibiotics in the past 3 months.You have strong reactions to alcohol, such as feeling very sick or passing out, even after drinking a little.You have used nicotine products or marijuana occasionally in the past month.You currently use or have used tobacco or nicotine products.I am on medication that interacts with alcohol.You have smoked less than 100 cigarettes in your entire life.People who are not sick or have any medical conditions.You have had issues with alcohol or drugs in the past.I am between 21 and 45 years old and I drink alcohol.I do not have any health conditions worsened by alcohol, like diabetes or heart issues.I have used tobacco/nicotine products or marijuana in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (alcohol consumption)
- Group 2: Group II (biospecimen collection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation inviting participants aged eighteen and above?
"The requirements for enrolment in this trial are that the patient is between 18-45 years old. Evidently, there are far fewer studies targeting younger age demographics (89) than elderly populations (2502)."
Answered by AI
Does this experiment currently have any vacancies for participants?
"Correct. According to clinicaltrials.gov, this medical research is currently enrolling patients with the initial post date of July 8th 2022 and a most recent update on July 25th 2023. This trial requires 170 test subjects from one site only."
Answered by AI
What is the capacity of enrolment for this experiment?
"Affirmative. According to information on clinicaltrials.gov, this research trial is recruiting patients at the present time. The study was initially posted on July 8th 2022 and updated most recently on July 25th 2023. 170 individuals need to be selected from a single medical centre for inclusion in this project."
Answered by AI
Is it possible to join this medical research study?
"In order to qualify for this medical trial, a candidate must have Fanconi anemia and be between 18-45 years of age. At present, the team are looking to enrol approximately 170 individuals."
Answered by AI
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