UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063010 |
|---|---|
| Receipt number | R000072137 |
| Scientific Title | Nationwide Anaphylaxis Registry in Japan |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/21 15:06:47 |
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Basic information
Public title
Nationwide Anaphylaxis Registry in Japan
Acronym
Nationwide Anaphylaxis Registry in Japan
Scientific Title
Nationwide Anaphylaxis Registry in Japan
Scientific Title:Acronym
Nationwide Anaphylaxis Registry in Japan
Region
| Japan |
Condition
Condition
Allergy and Anaphylaxis
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to characterize the triggers, treatment, and management of anaphylaxis in Japan.
Basic objectives2
Others
Basic objectives -Others
this study aims to assess changes in these characteristics over time, through repeated surveys.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of anaphylaxis cases, distribution of triggers, and treatment.
Key secondary outcomes
Regional distribution of the number of anaphylaxis cases, triggers, and treatment, as well as the rate of epinephrine auto-injector use.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who develop anaphylaxis during the study period and meet either of the following criteria: (1) patients who develop anaphylaxis at a participating institution; or (2) patients who visit a participating institution for an emergency or unscheduled visit because of anaphylaxis. No restrictions are placed on age or sex.
Key exclusion criteria
(1) Anaphylaxis occurring as a result of oral food challenges, other provocation tests, or immunotherapy performed in a medical institution. (2) Patients considered inappropriate for inclusion in the study by the attending physician.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Sakura |
| Middle name | |
| Last name | Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
ssakura8010@foodallergy.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kodachi |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
TEL
042-742-8311
Homepage URL
r1219kt@jichi.ac.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sagamihara Hospital Ethics Committee of the National Hospital Organization
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa
Tel
042-742-8311
makino.megumi.bn@mail.hosp.go.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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Survey Items
The following clinical information will be obtained from the medical records of study participants:
Patient characteristics: Age, sex, history of allergic symptoms, history of anaphylaxis, prior prescription of an epinephrine (adrenaline) auto-injector, and underlying medical conditions.
Clinical course of anaphylaxis: Date and place of onset, causative allergen, basis for diagnosis, cofactors, symptoms observed during the episode, occurrence of a biphasic reaction, and clinical outcome within seven days of onset.
Treatment: Use of an epinephrine auto-injector, number of epinephrine doses administered at medical institutions, hospitalization, prescription of an epinephrine auto-injector, and plans for subsequent follow-up care.
Methods
Clinical information will be collected using questionnaires submitted by mail or through a web-based survey form. The collected data will be compiled and analyzed by the study coordinating office at the National Hospital Organization Sagamihara National Hospital. The study results will be published on the study website.
Management information
Registered date
| 2026 | Year | 09 | Month | 21 | Day |
Last modified on
| 2026 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072137
