UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063568 |
|---|---|
| Receipt number | R000072745 |
| Scientific Title | Assessment of the Disease Burden of Hymenoptera Venom Allergy in Japan and Foundational Research for the Implementation of Venom Immunotherapy: A Retrospective Study of Patients Receiving Venom Immunotherapy and a Nationwide Survey of the General Population |
| Date of disclosure of the study information | 2026/11/10 |
| Last modified on | 2026/11/09 15:15:17 |
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Basic information
Public title
Assessment of the Disease Burden of Hymenoptera Venom Allergy in Japan and Foundational Research for the Implementation of Venom Immunotherapy: A Retrospective Study of Patients Receiving Venom Immunotherapy and a Nationwide Survey of the General Population
Acronym
Study on Hymenoptera Venom Allergy and Its Treatment in Japan
Scientific Title
Assessment of the Disease Burden of Hymenoptera Venom Allergy in Japan and Foundational Research for the Implementation of Venom Immunotherapy: A Retrospective Study of Patients Receiving Venom Immunotherapy and a Nationwide Survey of the General Population
Scientific Title:Acronym
Study on the Burden of Hymenoptera Venom Allergy and Venom Immunotherapy in Japan
Region
| Japan |
Condition
Condition
Hymenoptera stings and venom allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the burden of Hymenoptera venom allergy in Japan, evaluate the effectiveness, safety, and long-term outcomes of venom immunotherapy (VIT), and provide evidence to support the implementation of VIT in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1: Retrospective Study of Patients Who Have Received Venom Immunotherapy in Japan
Types, severity, and incidence of adverse events associated with venom immunotherapy (VIT), including local and systemic reactions.
Occurrence and severity of systemic allergic reactions following subsequent Hymenoptera stings during or after VIT.
Study 2: Nationwide Cross-Sectional Web-Based Survey of the General Population
Prevalence of Hymenoptera stings within the past five years.
Prevalence of anaphylaxis following Hymenoptera stings.
Proportion of respondents expressing willingness to receive venom immunotherapy (VIT).
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Study 1: Retrospective Study of Patients Who Have Received Venom Immunotherapy
1. Patients aged 20 years or older at the time of the survey.
2. Patients who received at least one administration of venom immunotherapy (VIT) using Hymenoptera venom allergen extracts manufactured by Jubilant HollisterStier at
Sagamihara National Hospital or Dokkyo Medical University Saitama Medical Center between January 1, 2000, and the date of institutional approval of the study.
3. Patients whose medical records contain sufficient information regarding VIT administration, including the type of venom allergen, dose, and treatment duration.
4. For the follow-up questionnaire survey assessing long-term outcomes and quality of life, patients with available contact information who provide informed consent to participate.
Study 2: Nationwide Cross-Sectional Web-Based Survey of the General Population
1. Individuals aged 20-64 years at the time of the survey.
2. Individuals registered as survey panel members with Macromill, Inc.
3. For the main survey, individuals who report a history of Hymenoptera stings within the past five years during the screening survey.
4. Individuals who provide consent to participate in the survey and to allow their responses to be used for research purposes, both at the beginning of the survey and after receiving the study information presented before final submission.
Key exclusion criteria
Study 1: Retrospective Study of Patients Who Have Received Venom Immunotherapy
1. Patients whose medical records contain insufficient information to confirm the details of VIT administration and clinical outcomes.
2. Patients who have expressed their refusal to allow the use of their medical information for this study.
3. Patients deemed unsuitable for participation by the principal investigator.
Study 2: Nationwide Cross-Sectional Web-Based Survey of the General Population
1. Individuals who do not consent to participate in the survey or to allow their responses to be used for research purposes.
2. Individuals whose responses contain substantial inconsistencies that compromise data reliability.
3. Individuals deemed unsuitable for participation by the principal investigator.
Target sample size
5150
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kamide |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
2520392
Address
18-1 Sakuradai, Minamiku Sagamihara, Kanagawa, Japan
TEL
0427428311
m08702012@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Kamide |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
2520392
Address
18-1 Sakuradai, Minamiku Sagamihara, Kanagawa, Japan
TEL
0427428311
Homepage URL
m08702012@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, NHO Sagamihara National Hospital
Address
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
0427428311
222-rinri@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 | 11 | Month | 10 | 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 | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional observational study consisting of two components.
Study 1: Multicenter Retrospective Cohort Study
Patients who previously received venom immunotherapy (VIT) at Sagamihara National Hospital or Dokkyo Medical University Saitama Medical Center will be retrospectively evaluated using medical records. Data on VIT administration, adverse events, systemic allergic reactions following subsequent Hymenoptera stings, and long-term clinical outcomes will be collected. In addition, a questionnaire survey will be conducted among contactable patients to assess quality of life, anxiety related to Hymenoptera stings, and employment status after treatment.
Study 2: Nationwide Cross-Sectional Web-Based Survey
An anonymous two-stage web-based survey will be conducted among individuals aged 20-64 years in Japan. The first stage will assess the prevalence of Hymenoptera stings. The second stage will target respondents who experienced Hymenoptera stings within the past five years and will assess the prevalence of anaphylaxis, healthcare utilization, diagnosis of venom allergy, awareness of VIT, and willingness to receive VIT. Stratified analyses will be performed according to occupation, geographic region, age, and sex.
Management information
Registered date
| 2026 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072745
