UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057802
Receipt number R000066059
Scientific Title Disease awareness and perspective of secondary immunodeficiency in Japanese physician -a web-based survey
Date of disclosure of the study information 2025/05/08
Last modified on 2025/05/08 19:06:32

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Basic information

Public title

Disease awareness and perspective of secondary immunodeficiency in Japanese physician -a web-based survey

Acronym

Disease awareness and perspective of secondary immunodeficiency in Japanese physician -a web-based survey

Scientific Title

Disease awareness and perspective of secondary immunodeficiency in Japanese physician -a web-based survey

Scientific Title:Acronym

Disease awareness and perspective of secondary immunodeficiency in Japanese physician -a web-based survey

Region

Japan


Condition

Condition

Secondary immunodeficiency

Classification by specialty

Medicine in general Hematology and clinical oncology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the level of disease awareness and perspective of SID practice among hematologists and infectious disease experts and internists in Japan.

Basic objectives2

Others

Basic objectives -Others

To elucidate the awareness and understanding of the treatment options for SID, and physician's clinical evaluation, diagnosis and management flow and treatment of SID.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The level of disease awareness and perspective of SID practice.(At the time of web survey)

Key secondary outcomes

Treatment options, clinical evaluation, diagnosis, standard of care and management flow of SID. (At the time of web survey)


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

Physicians in hematology, general internal medicine and infectious diseases departments who practice hematological diseases

Key exclusion criteria

・Physicians who have less than 3 years of practice excluding training period
・Physicians who work in a facility other than clinics, university hospitals, national and public hospitals, or public medical institutions/private hospitals
・Physicians who currently treating zero/none outpatients and inpatients
・Physicians who are related to Takeda and/or the Contract Research Organizations (CROs)

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Kaori
Middle name
Last name Nakagawa

Organization

Takeda Pharmaceutical Company Limited

Division name

Japan Medial Office

Zip code

103-8668

Address

1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo

TEL

03-3278-2111

Email

kaori.nakagawa@takeda.com


Public contact

Name of contact person

1st name Kiyoto
Middle name
Last name Naito

Organization

Takeda Pharmaceutical Company Limited

Division name

Japan Medial Office

Zip code

103-8668

Address

1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo

TEL

03-3278-2111

Homepage URL


Email

kiyoto.naito@takeda.com


Sponsor or person

Institute

Takeda Pharmaceutical Company Limited

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Company Limited

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

Takahashi Clinic Ethics Committee

Address

1F, Medical Hat, 5-1-31 Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo 657-0846

Tel

078-882-6432

Email

kishimoto.satoshi@neues.co.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

2025 Year 05 Month 08 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

Preinitiation

Date of protocol fixation

2025 Year 04 Month 02 Day

Date of IRB

2025 Year 04 Month 15 Day

Anticipated trial start date

2025 Year 05 Month 15 Day

Last follow-up date

2025 Year 05 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2025 Year 05 Month 08 Day

Last modified on

2025 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066059