UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029023 |
|---|---|
| Receipt number | R000033199 |
| Scientific Title | Survey of establishing novel management for pollen-food allergy syndrom in childhood |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/09/06 12:49:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey of establishing novel management for pollen-food allergy syndrom in childhood
Acronym
Survey of pollen-food allergy syndrom in childhood
Scientific Title
Survey of establishing novel management for pollen-food allergy syndrom in childhood
Scientific Title:Acronym
Survey of pollen-food allergy syndrom in childhood
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the distribution of causative antigens of pollen food allergy syndrome and the risk factor of anaphylaxis
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The distribution of causative foods and frequency of anaphylaxis
Key secondary outcomes
Age of onset
Presence or absence of pollinosis before onset
Rate of sensitization to pollen
Sensitization to allergen components and severity of induced symptoms
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases who diagnosed as pollen food allergy syndrome
Key exclusion criteria
There are no exclusion criteria
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakura Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, Sakuradai, Minami-ku, Sagamihara city, Kanagawa, Japan, 252-0392
TEL
042-742-8311
s-satou@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakura Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, Sakuradai, Minami-ku, Sagamihara city, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
s-satou@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構相模原病院（神奈川）、東京医科大学病院（東京）、東京医科大学八王子医療センター（東京）、熊本医療センター（熊本）、城北病院（石川）、竹田綜合病院（福島）、厚木市立病院（神奈川）、長後中央医院（神奈川）、こまたアレルギー科小児科クリニック（神奈川）、愛和病院（埼玉）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the distribution of causative foods and frequency of anaphylaxis
Management information
Registered date
| 2017 | Year | 09 | Month | 06 | Day |
Last modified on
| 2017 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
