UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035473 |
|---|---|
| Receipt number | 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 | 2022/07/12 09:38:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Syuji |
| Middle name | |
| Last name | Yonekura |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Otorhinolaryngology
Zip code
260-8677
Address
1-8-1 Inohana,Chuo-ku Chiba, Japan
TEL
043-222-7171
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
260-8677
Address
1-8-1 Inohana,Chuo-ku Chiba, Japan
TEL
043-222-7171
Homepage URL
syonekura@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Themo Fisher Diagnostics K.K.
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
Chiba University
Address
1-8-1 Inohana,Chuo-ku Chiba, Japan
Tel
043-222-7171
syonekura@faculty.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 | 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
150
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 | 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
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.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 |
