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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029023
Receipt No. 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

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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
Email 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
Email s-satou@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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