UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030995 |
|---|---|
| Receipt number | R000035034 |
| Scientific Title | Investigator-initiated confirmatory study on breath acetaldehyde/ethanol ratio and ALDH2 genotype |
| Date of disclosure of the study information | 2018/02/08 |
| Last modified on | 2018/01/25 15:33:42 |
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Basic information
Public title
Investigator-initiated confirmatory study
on breath acetaldehyde/ethanol ratio and ALDH2 genotype
Acronym
Breath AERO study
Scientific Title
Investigator-initiated confirmatory study
on breath acetaldehyde/ethanol ratio and ALDH2 genotype
Scientific Title:Acronym
Breath AERO study
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To confirm the relationship between breath acetaldehyde/ethanol levels (A/E ratio) and inactive ALDH2 gene (ALDH2*2 allele), which is a high risk factor for esophageal cancer and head and neck cancer, and to investigate the cut off level and the range of A/E ratio for identifying carriers of the ALDH2*2 allele
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
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 the A/E ratio.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto University Hospital
Division name
Clinical Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Amanuma |
Organization
Kyoto University Hospital
Division name
Clinical Oncology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3518
Homepage URL
yusuke12@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nissha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院（京都府）、大阪治験病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035034
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| Registered date | File name |
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| Registered date | File name |
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