UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052882 |
|---|---|
| Receipt number | R000060343 |
| Scientific Title | A study of the predictive factors for the diagnosis of buckwheat allergy |
| Date of disclosure of the study information | 2023/11/23 |
| Last modified on | 2023/11/23 12:15:03 |
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Basic information
Public title
A study of the predictive factors for the diagnosis of buckwheat allergy
Acronym
A study of the predictive factors for the diagnosis of buckwheat allergy
Scientific Title
A study of the predictive factors for the diagnosis of buckwheat allergy
Scientific Title:Acronym
A study of the predictive factors for the diagnosis of buckwheat allergy
Region
| Japan |
Condition
Condition
Buckwheat allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to evaluating known predictors of buckwheat allergy diagnosis, we will examine new background factors that may be useful in improving diagnostic accuracy by taking a detailed history.
Basic objectives2
Others
Basic objectives -Others
Diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive factors for the diagnosis of buckwheat allergy
Key secondary outcomes
Usefulness of buckwheat-specific IgE antibody titers in the diagnosis of buckwheat allergy
Usefulness of skin prick test in the diagnosis of buckwheat allergy
Correlation of skin test results with multiple buckwheat extracts
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Positive buckwheat-specific IgE level of 0.35 UA/mL or greater
Those who are diagnosed with or suspected of buckwheat allergy
Patients who meet all of the above criteria
Key exclusion criteria
The consent of the patient or the patient's guardian cannot be obtained for research
Patients deemed inappropriate as research subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Pediatrics
Zip code
252-0392
Address
18-1 Sakuradai, Minami-ku, Sagamihara City, Kanagawa
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Chiba |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Pediatrics
Zip code
252-0392
Address
18-1 Sakuradai, Minami-ku, Sagamihara City, Kanagawa
TEL
042-742-8311
Homepage URL
mut_tousand@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Sagamihara National Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1 Sakuradai, Minami-ku, Sagamihara City, Kanagawa
Tel
042-742-8311
222-rinri@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: observational study (prospective cohort study)
Method of subject recruitment: all patients who visited our hospital between October 2023 and December 2025 and met the selection criteria
Measurements: total IgE levels, buckwheat-specific IgE antibody titers, and skin prick test wheal diameter
Management information
Registered date
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060343
