UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060633 |
|---|---|
| Receipt number | R000068989 |
| Scientific Title | A cross-sectional survey on genetic counseling and genetic testing in hemophilia carrier care in Japan |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/09 23:02:35 |
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Basic information
Public title
A cross-sectional survey on genetic counseling and genetic testing in hemophilia carrier care in Japan
Acronym
A cross-sectional survey on genetic counseling and genetic testing in hemophilia carrier care in Japan
Scientific Title
A cross-sectional survey on genetic counseling and genetic testing in hemophilia carrier care in Japan
Scientific Title:Acronym
A cross-sectional survey on genetic counseling and genetic testing in hemophilia carrier care in Japan
Region
| Japan |
Condition
Condition
Hemophilia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the current practice of genetic counseling and genetic testing for hemophilia carrier diagnosis across specialized hemophilia care centers in Japan.
Basic objectives2
Others
Basic objectives -Others
To identify barriers and unmet needs toward improving and standardizing carrier care nationwide.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether each institution provides (1) genetic counseling and (2) genetic testing-based hemophilia carrier diagnosis.
Key secondary outcomes
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
The physician representative of each block core hospital designated by the Hemophilia Care Network Committee of the Japan Society on Thrombosis and Hemostasis (17 institutions, excluding Tokyo Medical University Hospital).
The physician representative of each regional core hospital designated by the Hemophilia Care Network Committee of the Japan Society on Thrombosis and Hemostasis (92 institutions).
Key exclusion criteria
Individuals who do not provide consent to participate in the questionnaire (i.e., do not agree / do not check the consent box)
Target sample size
109
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Bingo |
Organization
Tokyo Medical University
Division name
Department of Laboratory Medicine
Zip code
1600023
Address
6-7-1 Nishi-shinjuku, Shinjuku city, Tokyo, Japan
TEL
0333426111
bingo@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Bingo |
Organization
Tokyo Medical University
Division name
Department of Laboratory Medicine
Zip code
1600023
Address
6-7-1 Nishi-shinjuku, Shinjuku city, Tokyo, Japan
TEL
0333426111
Homepage URL
bingo@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Masato Bingo
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1 Nishi-shinjuku, Shinjuku-city, Tokyo
Tel
0333426111
IRB@tokyo-med.ac.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
| 2026 | Year | 02 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to conduct a cross-sectional survey on current clinical practice regarding genetic counseling and genetic testing for hemophilia carriers in Japan, to identify challenges in medical care and issues related to the dissemination and implementation of genetic counseling and genetic testing for carrier diagnosis, and to clarify the current situation. Through this work, we aim to improve and standardize the quality of hemophilia carrier care nationwide. The primary outcome is whether genetic counseling and carrier diagnosis using genetic testing for hemophilia carriers are provided at each medical institution in Japan. The study participants will be representatives of block hub hospitals and regional core hospitals certified by the Hemophilia Care Network Committee. This study is designed as a cross-sectional study using an anonymous questionnaire survey. The target number of participating institutions is 109, and the study period will be from the date of approval by the head of the research institution to March 31, 2027.
Management information
Registered date
| 2026 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068989
