UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049360 |
|---|---|
| Receipt number | R000056159 |
| Scientific Title | Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice (CHOICE) in JAPAN |
| Date of disclosure of the study information | 2022/10/28 |
| Last modified on | 2024/09/03 20:46:40 |
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Basic information
Public title
Criteria Used by Health Professionals on the
Selection of Allergen Immunotherapy in Real Clinical Practice (CHOICE) in JAPAN
Acronym
CHOICE-JAPAN
Scientific Title
Criteria Used by Health Professionals on the
Selection of Allergen Immunotherapy in Real Clinical Practice (CHOICE) in JAPAN
Scientific Title:Acronym
CHOICE-JAPAN
Region
| Japan |
Condition
Condition
allergic respiratory diseases
Classification by specialty
| Clinical immunology | Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent hypersensitivity to aeroallergens. These are called "drivers of prescription".
Among the different criteria selected by participants, the order of priority of AIT drivers will be established.
Key secondary outcomes
For sublingual immunotherapy, symptoms at initial induction.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
#Patients
Adults and children, males and females, with IgE-mediated pollen, house dust mites, animal dander, and moulds respiratory allergy who will initiate aeroallergen AIT, either SCIT, SLIT-drops, or SLIT-tablets according to real life clinical standards of practice
#Prescribers
Doctors who are currently prescribing AIT as part of their regular clinical practice
Key exclusion criteria
(i) Patients and physicians who refused to participate in the study
(ii) AIT for food
(iii) AIT for toxic substances
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Ebisawa |
| Middle name | |
| Last name | Motohiro |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa, JAPAN
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Fusayasu |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai, Minamiku, Sagamihara, Kanagawa, JAPAN
TEL
042-742-8311
Homepage URL
nen19842000@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Sagamihara National Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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
新橋アレルギー・リウマチクリニック、埼玉医科大学病院、東京医科大学病院、牛久愛和総合病院、東邦大学医療センター大橋病院、成城ささもと小児科アレルギー科、武蔵小杉ささもと小児科アレルギー科、水戸済生会総合病院、福岡大学病院、長後中央医院、おださが小児アレルギー科、まなべ小児科クリニック、さがみこどもアレルギークリニック、すこやかこどもクリニック 三ツ境、村野小児科アレルギー科、望月耳鼻咽喉科、わたせ耳鼻咽喉科、よしもと小児科、関西医科大学香里病院、ゆたクリニック、地方独立行政法人 大阪府立病院機構大阪はびきの医療センター、鶴川診療所、もみやま耳鼻咽喉科、ミューザ川崎こどもクリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Firstly, each investigator will complete the Doctor questionnaires to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).
On the other hand, at each AIT prescription to a patient, doctors will complete the Patient questionnaires to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ).
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056159
