UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057727 |
|---|---|
| Receipt number | R000065943 |
| Scientific Title | Pathophysiological Analysis of Drug-induced Allergic Diseases Including Perioperative Anaphylaxis and Desensitization Allergy |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2025/04/27 10:42:54 |
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Basic information
Public title
Pathophysiological Analysis of Drug-induced Allergic Diseases Including Perioperative Anaphylaxis and Desensitization Allergy
Acronym
Pathophysiological Analysis of Drug-induced Allergic Diseases Including Perioperative Anaphylaxis and Desensitization Allergy
Scientific Title
Pathophysiological Analysis of Drug-induced Allergic Diseases Including Perioperative Anaphylaxis and Desensitization Allergy
Scientific Title:Acronym
Pathophysiological Analysis of Drug-induced Allergic Diseases Including Perioperative Anaphylaxis and Desensitization Allergy
Region
| Japan |
Condition
Condition
Anaphylaxis, drug-induced allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to isolate and culture leukocytes from the skin, mucosa, or peripheral blood of patients with perioperative anaphylaxis, drug eruptions, or those undergoing desensitization therapy, in order to analyze their specific responses to drugs, metals, pollen, food antigens, and other allergens. We will conduct protein- and gene-level analyses focusing primarily on granulocytes, as well as perform identification of causative antigens (causative drugs).
Basic objectives2
Others
Basic objectives -Others
We aim to explore methods to prevent drug eruptions and allergic reactions, identify useful biomarkers for diagnosis, and discover potential candidates for novel therapeutic agents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will investigate the relationships between patients' clinical symptoms, medical information, results of BAT, DLST, and skin allergy tests, and molecular findings such as mRNA expression in blood cells and skin-resident cells.
Key secondary outcomes
We will evaluate the diagnostic specificity of various diagnostic criteria for anaphylaxis, including the WAO criteria, the Brighton criteria, and composite scores.
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 have agreed to participate in this study will be selected from those who meet the eligibility criteria.
Key exclusion criteria
1) Patients who are unable to be informed of their diagnosis.
2) Patients whom the physician deems unsuitable for the study.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Takeya |
| Middle name | |
| Last name | Adachi |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3823
jpn4156@keio.jp
Public contact
Name of contact person
| 1st name | Utako |
| Middle name | |
| Last name | Karigane |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3823
Homepage URL
utakookata.derma@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Utako Karigane
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2034 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065943
