UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035250 |
|---|---|
| Receipt number | 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 | 2023/06/22 22:43:53 |
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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 | Eishin |
| Middle name | |
| Last name | Morita |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Dermatology
Zip code
6938501
Address
Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2210
emorita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Eishin |
| Middle name | |
| Last name | Morita |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Dermatology
Zip code
6938501
Address
Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2210
Homepage URL
ychinuki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
Enya-cho 89-1, Izumo, Shimane, 693-8501
Tel
0853202515
kenkyu@med.shimane-u.ac.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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040137
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040137
Number of participants that the trial has enrolled
168
Results
A genome-wide association study was conducted in a discovery set of 77 individuals with WDEIA and 924 control subjects via three genetic models.
A locus on chromosome 6, rs9277630, was associated with WDEIA in the dominant model (OR = 3.95 [95% CI, 2.31-6.73], p = 7.87 x108).
The HLA-DPB1*02:01:02 allele displayed the most significant association with WDEIA (OR = 4.51 [95% CI, 2.66-7.63], p = 2.28 x109).
Individuals carrying the HLA-DPB1*02:01:02 allele have a significantly increased risk of WDEIA.
Results date posted
| 2023 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
WDEIA patients; discovery set 77, replication set 91
Participant flow
77 patients for discovery set and 30 patients for replication set (total 107 patients) were recruited from 6 sites and 61 patients for replication set were recruited from another site. Blood samples were sent to the analysis site after anonymization.
Adverse events
None
Outcome measures
Diagnosis due to Inclusion criteria and wheat allergen-specific IgE values
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 15 | Day |
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
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040137
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