UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040831 |
|---|---|
| Receipt number | R000046179 |
| Scientific Title | Clinical and Epidemiological Study on Rare Allergen-Induced Anaphylaxis and Development of Novel Diagnostic Scheme for Unknown Anaphylaxis |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2023/01/13 16:12:46 |
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Basic information
Public title
Clinical and Epidemiological Study on Rare Allergen-Induced Anaphylaxis and Development of Novel Diagnostic Scheme for Unknown Anaphylaxis
Acronym
Uncover Reality of Anaphylaxis induced by Rare Allergens (URARA) study
Scientific Title
Clinical and Epidemiological Study on Rare Allergen-Induced Anaphylaxis and Development of Novel Diagnostic Scheme for Unknown Anaphylaxis
Scientific Title:Acronym
Uncover Reality of Anaphylaxis induced by Rare Allergens (URARA) study
Region
| Japan |
Condition
Condition
Anaphylaxis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of novel diagnostic scheme for rare allergen-induced anaphylaxis
Basic objectives2
Others
Basic objectives -Others
Development of standardized management
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basophile activation test (BAT), immunoassay platform (ISAC), detailed clinical information
Key secondary outcomes
1) Kind and prevalence of causal allergens
2) Age, gender, complication of comorbid allergic disease, primary illness, biomarker of allergy
3) Detailed information on induced symptom
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
1) Diagnosis of anaphylaxis based on the Japanese Society of Allergology's diagnostic criteria in anaphylaxis guideline.
2) Patients with rare or unknown allergen-induced anaphylaxis
Key exclusion criteria
1) Patients who are diagnosed with anaphylaxis induced by common allergens (e.g. hen's egg, cow's milk, wheat, buckwheat, crustacean, peanuts, nuts, and bee).
2) Anaphylaxis-like diseases such as mastocytosis
3) Multiple chemical sensitivity
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Hoshi |
Organization
National Hospital Organization Nagara Medical Center
Division name
Department of Clinical Research
Zip code
502-8558
Address
1300-7 Nagara, Gifu, Gifu 502-8558, Japan
TEL
058-232-7755
deep_snow_star@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Tanimura |
Organization
National Hospital Organization Mie National Hospital
Division name
Department of Clinical Research
Zip code
514-0125
Address
357 Osato-kubota, Tsu, Mie 514-0125, Japan
TEL
059-232-2531
Homepage URL
mieclinicalresearch@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagara Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Japan
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
N/A
Address
N/A
Tel
N/A
N/A
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
国立病院機構長良医療センター(岐阜県）
国立病院機構三重病院(三重県)
国立病院機構北海道医療センター(北海道)
国立病院機構新潟病院(新潟県）
国立病院機構相模原病院(神奈川県）
国立病院機構横浜医療センター(神奈川県）
国立病院機構名古屋医療センター(愛知県)
国立病院機構南岡山医療センター(岡山県）
国立病院機構福岡東医療センター(福岡県）
国立病院機構福岡病院(福岡県）
国立病院機構熊本医療センター(熊本県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 20 | 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
57
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Patients with unknown anaphylaxis are registered, and based on novel diagnostic procedures, expert allergist board identify causal rare allergen. Information on rare allergen are accumulated in the registry.
Descriptive statistics and hierarchical cluster analysis are utilized to identify phenotype of sensitization.
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046179
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
