Clinical trial · Interventional
Role of Acetaldehyde in the Development of Oral Cancer
Dissecting the Role of Acetaldehyde in Oral Carcinogenesis
NCT05973656CI-TRIAL-00118868recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol-Related Carcinoma | Alcohol-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Fanconi Anemia | — | UNRESOLVED | — |
| Oral Cavity Carcinoma | Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alcohol | Drug | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Breath Test | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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; * 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) Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.