UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048823 |
|---|---|
| Receipt number | R000055591 |
| Scientific Title | Anaphylaxis registry based on a network of the Allergic Disease Medical Core Hospital |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/11/29 14:39:05 |
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Basic information
Public title
Anaphylaxis registry based on a network of the Allergic Disease Medical Core Hospital
Acronym
Anaphylaxis registry based on a network of the Allergic Disease Medical Core Hospital
Scientific Title
Anaphylaxis registry based on a network of the Allergic Disease Medical Core Hospital
Scientific Title:Acronym
Anaphylaxis registry based on a network of the Allergic Disease Medical Core Hospital
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
We aim to identify the status of diagnosis, treatment, and management of anaphylaxis in Japan, and to monitor changes in this status.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes over years in the number of anaphylaxis cases, types of triggers, and treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients visited at a collaborating institution for treatment and examination after the onset of anaphylaxis.
Key exclusion criteria
1) Cases of anaphylaxis by oral food challenge or other induced tests.
2) Cases judged inappropriate by the 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
Department of pediatrics
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
Japanese Society of Allergology
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2022 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research and Survey Items
<Research Items>
The following clinical information on the research subjects will be obtained from their medical records.
Background factors: age, gender, history of anaphylaxis (triggers and frequency), complications, and prior prescription of adrenaline self-injection products.
Course of anaphylaxis: date of onset, place of onset, causative antigen, symptoms (all symptoms during the course of the disease, symptoms at the time of the visit), co-factors that amplify anaphylaxis, and turnaround time within 7 days.
Details of treatment: adrenaline autoinjector use, details of treatment at medical institution, presence of hospitalization, presence of intensive care management, department examined, department to follow up
<Method>
Clinical information will be collected by mail or via a web-based questionnaire form. The collected data will be tabulated by the research office of the National Hospital Organization Sagamihara National Hospital, and the results will be published on the website of this study.
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
