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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030995
Receipt No. 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

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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
Email 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
Email yusuke12@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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