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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024563
Receipt No. R000027560
Scientific Title Analysis of clinical characteristics of patients with macadamia nut allergy and identification of the macadamia nut allergens
Date of disclosure of the study information 2016/11/01
Last modified on 2018/04/26

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Basic information
Public title Analysis of clinical characteristics of patients with macadamia nut allergy and identification of the macadamia nut allergens
Acronym Identification of the macadamia nut allergens
Scientific Title Analysis of clinical characteristics of patients with macadamia nut allergy and identification of the macadamia nut allergens
Scientific Title:Acronym Identification of the macadamia nut allergens
Region
Japan

Condition
Condition Macadamia nut allergy
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate clinical characteristics of patients with macadamia nut allergy and identify the macadamia nut allergens.
Basic objectives2 Others
Basic objectives -Others Identification of the macadamia nut allergens
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Identification of the macadamia nut allergens
Key secondary outcomes 1. Cross-reactivity of macadamia nut with other foods
2. Association between sensitized components and clinical characteristics in patients with macadamia nut allergy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Immunological tests
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
0 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria Patients with macadamia nut allergy
Patients who were obtained oral consent to the study by parents or legal parents
Key exclusion criteria Patients who are considered to be ineligible by the doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Yoshida
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Allergy
Zip code
Address 2-8-29 Musashidai Fuchu, Tokyo
TEL 042-300-5111
Email kouichi_yoshida@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Yoshida
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Allergy
Zip code
Address 2-8-29 Musashidai Fuchu, Tokyo
TEL 042-300-5111
Homepage URL
Email kouichi_yoshida@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 東京都立小児総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 25 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027560

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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