UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038378
Receipt number R000043736
Scientific Title Examination of allergen-specific upregulation of thymic stromal lymphopoietin receptor on basophils from allergic rhinitis patients
Date of disclosure of the study information 2019/11/01
Last modified on 2022/04/26 12:16:50

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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 or person

Institute

Department of Otorhinolaryngology, Graduate School of Medicine, Chiba University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043736


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name