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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035250
Receipt No. R000040137
Scientific Title A study for gene polymorphisms related to wheat allergy
Date of disclosure of the study information 2018/12/14
Last modified on 2018/12/19

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Basic information
Public title A study for gene polymorphisms related to wheat allergy
Acronym A study for gene polymorphisms related to wheat allergy
Scientific Title A study for gene polymorphisms related to wheat allergy
Scientific Title:Acronym A study for gene polymorphisms related to wheat allergy
Region
Japan

Condition
Condition Wheat allergy
Classification by specialty
Medicine in general Clinical immunology Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify a gene which associate with wheat allergy in Japanese population.
Basic objectives2 Others
Basic objectives -Others We will collect medical information and blood from wheat allergy patients. Extract genomic DNA from the collected blood. We will identify a gene which will be significantly associated with wheat allergy using single nucleotide polymorphism (SNP) covering the entire genome, and polymorphism analysis of several genes in the region where the SNP marker is present. As the number of specimens that can be collected at one facility is limited, multi-center collaborative research will be conducted, and a total of 400 specimens will be collected.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To identify a specific maker SNP aggregated in patients with wheat allergy by comparing whole genome SNP information of wheat allergy patients and sample Japanese population. Polymorphism analysis will be carried out for several genes present in the gene region where the marker exists. Further we will conduct an association analysis using a database of sample Japanese population and identify genes related to wheat allergy.
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who meets the following diagnostic criteria will be enrolled: the diagnostic criteria of wheat-dependent exercise-induced anaphylaxis made by study group of Guideline for the treatment of life-threatening food allergy, supported by Health and Labor Sciences Research Grant; Patients who have immediate allergic reactions to wheat after ingestion of wheat product, and have the positive reaction of serum wheat related antigen-specific IgE.
2. The age at the time of consent is 20 years old or over.
3. Agreement has been obtained from the principal concerning research participation in writing.
Key exclusion criteria No exclusion criteria
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eishin Morita
Organization Shimane University
Division name Faculty of Medicine, Department of Dermatology
Zip code
Address Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2210
Email emorita@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Chinuki
Organization Shimane University
Division name Faculty of Medicine, Department of Dermatology
Zip code
Address Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2210
Homepage URL
Email ychinuki@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Self funding
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 島根大学(島根県)Shimane University (Shimane)
藤田医科大学(愛知県)Fujita Health University (Aichi)
国立病院機構福岡病院(福岡県)National Hospital Organization, Fukuoka National Hospital (Fukuoka)
東京医科歯科大学(東京都)Tokyo Medical and Dental University (Tokyo)
大阪大学(大阪府)Osaka University (Osaka)
広島大学(広島県)Hiroshima University (Hiroshima)
兵庫県立加古川医療センター(兵庫県)Hyogo Prefectural Kakogawa Medical Center (Hyogo)
国立病院機構相模原病院(神奈川県)National Hospital Organization, Sagamihara National Hospital (Kanagawa)
神戸大学(兵庫県)Kobe University (Hyogo)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 14 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a case-control comparison study.

Management information
Registered date
2018 Year 12 Month 14 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040137

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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