UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042088 |
|---|---|
| Receipt number | R000046157 |
| Scientific Title | Inherited Bone Marrow Failure Syndrome Registry |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2020/10/12 17:37:43 |
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Basic information
Public title
Inherited Bone Marrow Failure Syndrome Registry
Acronym
IBMFS Registry
Scientific Title
Inherited Bone Marrow Failure Syndrome Registry
Scientific Title:Acronym
IBMFS Registry
Region
| Japan |
Condition
Condition
Inherited bone marrow failure syndrome
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To study the clinical course and clinical feature of inherited bone marrow failure syndrome.
Basic objectives2
Others
Basic objectives -Others
To investigate the effect and safety profile of therapeutic agents administered for inherited bone marrow failure syndrome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
none
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
Patients diagnosed with inherited bone marrow failure syndrome.
Key exclusion criteria
Those who judged to be ineligibility in the study by researchers.
Target sample size
9999
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Ito |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Community Medicine
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori, Japan
TEL
0172-39-5070
eturou@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiminori |
| Middle name | |
| Last name | Terui |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori, Japan
TEL
0172-39-5070
Homepage URL
teru@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
弘前大学医学部附属病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 01 | 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
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study intends to collect medical information on inherited bone marrow failure syndrome patients and build a patient registry.
Management information
Registered date
| 2020 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046157
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
