UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024563 |
|---|---|
| Receipt number | 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 | 2019/10/29 15:50:37 |
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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
| Not applicable |
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 | Koichi |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Allergy
Zip code
1838561
Address
2-8-29 Musashidai Fuchu, Tokyo
TEL
042-300-5111
kouichi_yoshida@tmhp.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Allergy
Zip code
1838561
Address
2-8-29 Musashidai Fuchu, Tokyo
TEL
042-300-5111
Homepage URL
kouichi_yoshida@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai Fuchu Tokyo
Tel
042-300-5111
sn_chiken-jimu@tmhp.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
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
7
Results
Results date posted
| 2019 | Year | 10 | Month | 29 | Day |
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
| 2016 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027560
