UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049579 |
|---|---|
| Receipt number | R000056302 |
| Scientific Title | The Study of Diagnostic tool for Adult Food Allergy |
| Date of disclosure of the study information | 2022/11/22 |
| Last modified on | 2024/05/25 01:25:43 |
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Basic information
Public title
The Study of Diagnostic tool for Adult Food Allergy
Acronym
The Study of Diagnostic tool for Adult Food Allergy
Scientific Title
The Study of Diagnostic tool for Adult Food Allergy
Scientific Title:Acronym
The Study of Diagnostic tool for Adult Food Allergy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adult food allergy is not rare, but the diagnosis is difficult. We made the supportive tool for the diagnosis of food allergy. The objective of this study is to evaluate the efficacy of the tool.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the people who has chosen every examination which over 70% of well experienced doctors have chosen.
Key secondary outcomes
the rate of the people who chose View-39
the collect answer rate of the quetion about the knowledge of food allergy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The group using the supportive tool for diagnosis.
Interventions/Control_2
The group not using the supportive tool for diagnosis.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The doctors who are not expert of allergy and who have agreed to participate in the study.
Key exclusion criteria
The expert of allergy.
The person who have read "adult food allergy" published by Bunko-do in 2021.
The person who have already participated in preliminary test.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Masaki |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine, Division of Pulmonary Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
masakik@keio.jp
Public contact
Name of contact person
| 1st name | Shunichiro |
| Middle name | |
| Last name | Konishi |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine, Division of Pulmonary Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
Homepage URL
shunichirokonishi0828@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Hospital
Showa University Hospital
National Hospital Organization Mie Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee Bureau
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 22 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056302
