UMIN-CTR Clinical Trial

Basic information
Public title	Examination of allergen-specific upregulation of thymic stromal lymphopoietin receptor on basophils from allergic rhinitis patients
Acronym	Examination of allergen-specific upregulation of thymic stromal lymphopoietin receptor on basophils from allergic rhinitis patients
Scientific Title	Examination of allergen-specific upregulation of thymic stromal lymphopoietin receptor on basophils from allergic rhinitis patients
Scientific Title:Acronym	Examination of allergen-specific upregulation of thymic stromal lymphopoietin receptor on basophils from allergic rhinitis patients
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 allergen specific upregulation of thymic stromal lymphopoietin receptor of basophils from allergic rhinitis patients for the diagnosis of allergic rhinitis
Basic objectives2	Others
Basic objectives -Others	To evaluate clinical performance of upregulation of thymic stromal lymphopoietin receptor of basophils 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 allergen-specific upregulation of thymic stromal lymphopoietin receptor of basophils
Key secondary outcomes	- ROC analysis and estimate sensitivity, specificity, predictive values with the optimal cutoff

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	135

Research contact person
Name of lead principal investigator	1st name Syuji Middle name Last name Yonekura
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otorhinolaryngology
Zip code	260-8670
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 Syuji Middle name Last name Yonekura
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otorhinolaryngology
Zip code	260-8670
Address	1-8-1 Inohana,Chuo-ku Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	syonekura@faculty.chiba-u.jp

Sponsor
Institute	Department of Otorhinolaryngology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Department of Otorhinolaryngology, Graduate School of Medicine, Chiba University
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	Chiba university
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi
Tel	043-222-7171
Email	jibika@office.chiba-u.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	2019 Year 11 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	Completed
Date of protocol fixation	2018 Year 12 Month 25 Day
Date of IRB	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2022 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 10 Month 24 Day
Last modified on	2022 Year 04 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043736