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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035473
Receipt No. R000040291
Scientific Title Clinical performance study of specific IgE test of house dust mite allergen components
Date of disclosure of the study information 2019/03/01
Last modified on 2019/07/09

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Basic information
Public title Clinical performance study of specific IgE test of house dust mite allergen components
Acronym Clinical performance study of specific IgE test of house dust mite allergen components
Scientific Title Clinical performance study of specific IgE test of house dust mite allergen components
Scientific Title:Acronym Clinical performance study of specific IgE test of house dust mite allergen components
Region
Japan

Condition
Condition Allergic rhinitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical utility of specific IgE test of house dust mite allergen components for the diagnosis of allergic rhinitis
Basic objectives2 Others
Basic objectives -Others To evaluate clinical performance of house dust mite allergen component-specific IgE test and compare with those of crude allergen extract-specific IgE test.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate clinical sensitivity, clinical specificity, positive predictive value and negative predictive value of house dust mite allergen component-specific IgE test and compare with those of crude allergen extract-specific IgE test
Key secondary outcomes - Distribution of the specific IgE levels
- ROC analysis and estimate sensitivity, specificity, predictive values with the optimal cutoff
- Assessment of relationship of specific IgE levels and nasal provocation outcome
- 95% positive predictive value of the specific IgE test

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Stop anti-allergic medication for 3 days before nasal provocation test.
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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria - Allergic rhinitis patients with positive specific IgE of house dust mite and be able to receive nasal provocation test
- Allergic rhinitis patients with negative specific IgE of house dust mite with no clinical history of house dust mite allergy
Key exclusion criteria - Severe bronchial asthma or sever atopic dermatitis
- Allergic rhinitis possibly caused by dog, cat, cockroach or moth
- Specific IgE level of dog, cat, cockroach or moth is higher than house dust mite or higher than 10UA/mL
- Received allergen-specific immunotherapy of house dust or house dust mite
- Medicated with inhaled corticosteroids within 3 months before blood collection
- Received anti-human IgE antibody therapy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Syuji Yonekura
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorhinolaryngology
Zip code
Address 1-8-1 Inohana,Chuo-ku Chiba, Japan
TEL 043-222-7171
Email syonekura@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Syuji Yonekura
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorhinolaryngology
Zip code
Address 1-8-1 Inohana,Chuo-ku Chiba, Japan
TEL 043-222-7171
Homepage URL
Email syonekura@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Themo Fisher Diagnostics
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2019 Year 03 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 22 Day
Date of IRB
2018 Year 12 Month 17 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2020 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
2019 Year 01 Month 07 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040291

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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