UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058448 |
|---|---|
| Receipt number | R000066829 |
| Scientific Title | Study on the Diagnostic Application of Allergen-Specific IgE Detection in Nasal Secretions Using Protein Microarray Chips |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/07/13 12:36:24 |
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Basic information
Public title
Nasal Allergen Specific IgE Detection Study
Acronym
Nasal Allergen Specific IgE Study
Scientific Title
Study on the Diagnostic Application of Allergen-Specific IgE Detection in Nasal Secretions Using Protein Microarray Chips
Scientific Title:Acronym
NASIED Study
Region
| Japan |
Condition
Condition
Allergic Rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of measuring allergen-specific IgE in nasal secretions as a diagnostic method for allergic rhinitis.
Basic objectives2
Others
Basic objectives -Others
To evaluate the correlation with clinical symptoms and the association with local allergic rhinitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity of allergen-specific IgE measurement in nasal secretions
Key secondary outcomes
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
Collection of nasal secretion
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are receiving care at the International University of Health and Welfare Narita Hospital and have already undergone blood collection
Patients from whom written informed consent for participation in the study can be voluntarily obtained
Patients aged 18 years or older and under 80 years at the time of consent
Inpatients
Patients confirmed to be negative for HBV and HCV by blood tests
Key exclusion criteria
Patients from whom informed consent could not be obtained
Patients who are using intranasal steroid sprays or systemic steroid medications
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Okano |
Organization
International University of Health and Welfare Narita Hospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2868686
Address
852 Hatakeda, Narita
TEL
0476-35-5600
mokano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Maruyama |
Organization
International University of Health and Welfare Narita Hospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2868686
Address
852 Hatakeda, Narita
TEL
09046948005
Homepage URL
jibika@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare Ethics Review Board for Clinical Research
Address
852 Hatakeda, Narita
Tel
0476355600
mokano@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2025 | Year | 07 | Month | 13 | Day |
Last modified on
| 2025 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066829
