healthy volunteers
Conditions
Interventions
By using FIS-14012, we measure the acetaldehyde and ethanol concentrations of end-tidal gas, which was collected immediately 1 and 5 min after drinking the alcohol (0.5% ethanol, 100mL) and calculate
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who receive no clinical treatment and use no drug now 2) AST, ALT and gamma-GTP are less than two times of upper limit of local reference 3) Subjects who receive a full explanation of the study and give a written informed consent.
Exclusion criteria
Exclusion criteria: 1) With alcohol allergy 2) Previous history of esophagectomy, gastrectomy, hepatectomy or pancreatectomy (excluding endoscopic treatments) 3) Previous history of cancer treatments except for endoscopic treatments 4) Women who are pregnant, breast feeding or possible to be pregnant 5) Subjects who participate in other clinical trials 6) Subjects whom the investigator judges not to be appropriate for the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of the A/E ratio 1 min after drinking alcohol (0.5% ethanol) for identifying carriers of the ALDH2*2 allele | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The sensitivity and specificity of the A/E ratio 5 min after drinking alcohol (0.5% ethanol) for identifying carriers of the ALDH2*2 allele 2)The sensitivity and specificity of the flushing questionnaire for identifying carriers of the ALDH2*2 allele | — |
Countries
Japan
Contacts
Public ContactYusuke Amanuma
Kyoto University Hospital Clinical Oncology
Outcome results
None listed