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 2022/11/07 16:32:30

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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

Email

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


Email

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

Email

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

Completed

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

2022 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name