UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063237 |
|---|---|
| Receipt number | R000071926 |
| Scientific Title | MRGPRX2 variants and anaphylaxis |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/10 18:56:34 |
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Basic information
Public title
MRGPRX2 variants and anaphylaxis
Acronym
MRGPRX2 variants and anaphylaxis
Scientific Title
MRGPRX2 variants and anaphylaxis
Scientific Title:Acronym
MRGPRX2 variants and anaphylaxis
Region
| Japan |
Condition
Condition
Anaphylaxis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate MRGPRX2 genetic variants in patients with anaphylaxis and to explore whether these variants are associated with the development and severity of anaphylaxis.
Basic objectives2
Others
Basic objectives -Others
Exploration of the association between MRGPRX2 genetic variants and anaphylaxis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence and types of MRGPRX2 genetic variants in patients with anaphylaxis.
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
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing diagnostic testing to identify the causative agent of anaphylaxis in either of the following studies are eligible: the JESPA (Japanese Epidemiologic Study of Perioperative Anaphylaxis) conducted at Gunma University Hospital and Saiseikai Matsuyama Hospital or the Investigation of Causative Agents in Allergic Reactions Occurring Inside and Outside the Hospital, conducted at Gunma University Hospital.
In the JESPA, patients with suspected perioperative anaphylaxis are eligible.
In the Investigation of Causative Agents in Allergic Reactions Occurring Inside and Outside the Hospital, patients who develop Grade 2 or higher anaphylactic reactions at Gunma University Hospital, or patients who develop Grade 2 or higher anaphylactic reactions at another hospital and are referred to Gunma University Hospital, are eligible.
Key exclusion criteria
1. Patients who are determined not to have anaphylaxis after diagnostic evaluation.
2. Patients who are considered unsuitable for participation in this study by the investigators.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Horiuchi |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
3718511
Address
3-39-15, Showa-machi, Maebashi
TEL
0272207111
horiuchi-t@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Horiuchi |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi
TEL
0272207111
Homepage URL
horiuchi-t@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University
Saiseikai Matsuyama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa-machi, Maebashi
Tel
0272207111
ciru_hitotaisho-irb@ml.gunma-u.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
群馬大学医学部附属病院（群馬県）
済生会松山病院（愛媛県）
愛媛大学（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | 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 | 09 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 multicenter observational study involving patients with anaphylaxis.
Blood samples will be newly collected from patients for analysis of the MRGPRX2 gene region. Genetic analysis will be performed at the Department of Pharmacology, Ehime University.
MRGPRX2 genetic data obtained from healthy controls in a separate study conducted at Ehime University will be used as comparative control data.
MRGPRX2 genetic variants will be compared between patients with anaphylaxis and healthy controls. Potential associations between these variants and the occurrence and severity of anaphylaxis will also be explored.
This study will be conducted collaboratively by Gunma University, Ehime University, and Saiseikai Matsuyama Hospital.
Management information
Registered date
| 2026 | Year | 10 | Month | 10 | Day |
Last modified on
| 2026 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071926
