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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09710 | Registry Identifier | NCI Trial ID |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group II (biospecimen collection) | Active Comparator | Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Prior to alcohol exposure |
| Urine will be analyzed to confirm non-smoking status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Balbo Silvia, PhD | Contact | 612-624-4240 | balbo006@umn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D005199 | Fanconi Anemia |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D029502 | Anemia, Hypoplastic, Congenital |
| D000741 | Anemia, Aplastic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Biospecimen Collection | Procedure | Undergo saliva, mouthwash, and cheek brush collection |
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| Breath Test | Procedure | Undergo breathalyzer testing |
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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. |
| Up to 6 hours after alcohol exposure |
| D006425 |
| Hemic and Lymphatic Diseases |
| D000080984 | Congenital Bone Marrow Failure Syndromes |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |