Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05973656
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Acetaldehyde in the Development of Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005199', 'term': 'Fanconi Anemia'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D029502', 'term': 'Anemia, Hypoplastic, Congenital'}, {'id': 'D000741', 'term': 'Anemia, Aplastic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080984', 'term': 'Congenital Bone Marrow Failure Syndromes'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the acetaldehyde exposure to the oral cavity by comparing saliva levels before and after alcohol dose', 'timeFrame': 'Prior to alcohol dose, and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post alcohol dose', 'description': 'Identify and quantify DNA adducts in the oral cells (mouthwash and cheek brush samples).'}], 'secondaryOutcomes': [{'measure': 'Urine will be analyzed to confirm non-smoking status', 'timeFrame': 'Prior to alcohol exposure', 'description': '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.'}, {'measure': 'Urine will be analyzed to confirm non-smoking status', 'timeFrame': 'Up to 6 hours after alcohol exposure', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol-Related Carcinoma', 'Fanconi Anemia', 'Oral Cavity Carcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21-45 years of age for alcohol drinkers\n* Occasionally consume alcohol\n* At least 1 drink per month for healthy volunteers\n* At least 1 drink in the last 3 months for Fanconi anemia patients\n* Meets one of the three criteria\n* Healthy volunteer - ALDH2\\*1/1\\* homozygotes-not of Eastern Asian decent;\n* Healthy volunteer - ALDH2\\*1/2\\* heterozygotes-of Eastern Asian decent and experience flushing when drinking\n* Individual\'s with Fanconi anemia (FA).\n* 18-45 years of age for non-drinkers\n* Never consume alcohol/not had alcohol in the last 6 months\n* Healthy volunteers.\n* Non-smoker (smoked \\< 100 cigarettes in a lifetime)\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption\n* Healthy volunteers who have taken any antibiotics in the last 3 months\n* Currently consuming more than 21 drinks per week\n* Have any history of alcohol or drug related problems\n* Current or former tobacco/nicotine product(s) user\n* Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)\n* "Trying" or limited use of any nicotine products or marijuana in the last 1 month\n* Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission in the study will be delayed pending improved health\n* Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)\n* Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol'}, 'identificationModule': {'nctId': 'NCT05973656', 'briefTitle': 'Role of Acetaldehyde in the Development of Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Dissecting the Role of Acetaldehyde in Oral Carcinogenesis', 'orgStudyIdInfo': {'id': 'SPH-2021-29712'}, 'secondaryIdInfos': [{'id': 'NCI-2022-09710', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (alcohol consumption)', 'description': '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.', 'interventionNames': ['Drug: Alcohol', 'Procedure: Biospecimen Collection', 'Procedure: Breath Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (biospecimen collection)', 'description': 'Participants who do not drink alcohol undergo collection of saliva, mouthwash, and cheek brush samples throughout the trial.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Breath Test']}], 'interventions': [{'name': 'Alcohol', 'type': 'DRUG', 'description': 'Alcohol dose given orally that will result in a 0.03% blood alcohol concentration (BAC).', 'armGroupLabels': ['Group I (alcohol consumption)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo saliva, mouthwash, and cheek brush collection', 'armGroupLabels': ['Group I (alcohol consumption)', 'Group II (biospecimen collection)']}, {'name': 'Breath Test', 'type': 'PROCEDURE', 'description': 'Undergo breathalyzer testing', 'armGroupLabels': ['Group I (alcohol consumption)', 'Group II (biospecimen collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Balbo Silvia, PhD', 'role': 'CONTACT', 'email': 'balbo006@umn.edu', 'phone': '612-624-4240'}], 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Balbo Silvia, PhD', 'role': 'CONTACT', 'email': 'balbo006@umn.edu', 'phone': '612-624-4240'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}