An interventional study of Alcohol and Biospecimen Collection in Alcohol-Related Carcinoma, Fanconi Anemia and Oral Cavity Carcinoma, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Basic science
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.
95 studies on the registry are indexed under Fanconi Anemia; 20 are open to participants now.
This study's planned enrollment of 170 is above the median of 21 across 61 interventional studies indexed under Fanconi Anemia.
Browse Fanconi Anemia studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 286 studies on the registry; 35 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
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Exclusion Criteria:
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.
Drug: Alcohol · Procedure: Biospecimen Collection · Procedure: Breath Test
Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.
Procedure: Biospecimen Collection · Procedure: Breath Test
Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).
Undergo saliva, mouthwash, and cheek brush collection
Undergo breathalyzer testing
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).
Time frame: Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose
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.
Time frame: 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.
Time frame: Up to 6 hours after alcohol exposure
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Ethanol
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