UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043088 |
|---|---|
| Receipt number | R000049099 |
| Scientific Title | Physician Awareness and Understanding of Primary Immunodeficiency Disorder: A Web-based Study |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2024/07/05 09:55:43 |
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Basic information
Public title
Physician Awareness and Understanding of Primary Immunodeficiency Disorder:
A Web-based Study
Acronym
PID-JAPAN physician survey study
Scientific Title
Physician Awareness and Understanding of Primary Immunodeficiency Disorder:
A Web-based Study
Scientific Title:Acronym
PID-JAPAN physician survey study
Region
| Japan |
Condition
Condition
Primary Immunodeficiency Disorder
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Pediatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the level of awareness of PID and understanding the diagnostic flow in PID in clinical practice
Basic objectives2
Others
Basic objectives -Others
To determine the level of awareness of PID and understanding the diagnostic flow in PID in clinical practice
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the level of awareness of PID and understanding the diagnostic flow in PID in clinical practice
Key secondary outcomes
To determine the DDx between PID w/o IgG deficits including current treatment of PID
To determine the awareness and usefulness of TIPs(10 warning signs) to consider PID in clinical settings.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Physicians registered to Nikkei BP panel.
2)Physicians certified by medical societies as; General internal medicine and/or Pediatrics and/or Hematology.
Key exclusion criteria
1) Have less than 2 year of practice excluding training period
2) Work in a facility other than clinics, university hospitals, general hospitals and; national and public hospitals
3) Currently treating 0 outpatients and inpatients
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | 1)Yoich, 2)Kohsuke |
| Middle name | |
| Last name | 1) Inoue, 2) Imai |
Organization
1)Takeda Pharmaceutical Company Limited
2)National Defense Medical College
Division name
1)Japan Medical Office, 2)Department of Pediatrics
Zip code
103-8668
Address
1) 1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan
TEL
070-4921-7478
yoichi.inoue@takeda.com
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Oh |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan
TEL
080-2413-7663
Homepage URL
akinori.oh@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
NA
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
https://doi.org/10.1080/25785826.2022.2137966
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/25785826.2022.2137966
Number of participants that the trial has enrolled
355
Results
45% physicians knew PID's symptoms and clinical conditions but 20% was aware of the diagnostic criteria and the recommended treatment. After presentation of patients' medical history, 74% physicians suspected PID and 60% physicians considered labo-tests for Serum IgG (IgA:55%, IgM:56%,IgE:33%). 72 physicians currently treated PID and 33% physicians who treated PID answered they control; serum immunoglobulin G trough level at 400-500 mg/dL, which is lower than the globally recommended standard value.
Results date posted
| 2022 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
355 physicians (121 pediatricians, 116 hematologists and 118 general internal medicine physicians)
Participant flow
A web-based survey was conducted between 25 Jan 2021 and 12 Feb 2021 among Japanese physicians who were registered by Nikkei BP. The survey included 10 warning signs of PID and original questionnaires.
Adverse events
NA
Outcome measures
NA
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Physician Awareness and Understanding of Primary Immunodeficiency Disorder:
A Web-based Study
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049099
