UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029195 |
|---|---|
| Receipt number | R000031524 |
| Scientific Title | Regitry building and biological sample banking of moyamoya disease in Japan |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2021/04/23 10:13:11 |
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Basic information
Public title
Regitry building and biological sample banking of moyamoya disease in Japan
Acronym
JMR
Scientific Title
Regitry building and biological sample banking of moyamoya disease in Japan
Scientific Title:Acronym
JMR
Region
| Japan |
Condition
Condition
moyamoya disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Main objective of this study is to build registry system of moyamoya disease in order to clarify natural history of various clinical phenotypes and to investigate relevance of environmental and genetic factors for onset, progression and outcome in moyamoya disease.
Basic objectives2
Others
Basic objectives -Others
Pathorogy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroke and radiographical progression of vascular disease.
Key secondary outcomes
Analysis of genome and epigenome by using blood, cerbrospinal fluid and saliva. Change of acitivities of daily living (ADL) and life history such as pregancy or delivery
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed as moyamoya disease.
Key exclusion criteria
Patients who deny to participate in this study.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Kiyohiro |
| Middle name | |
| Last name | Houkin |
Organization
Hokkaido University Hospital
Division name
Department of Neurosurgery
Zip code
0608638
Address
North-15, West-7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL
011-706-5987
houkin@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ito |
Organization
Hokkaido University Hospital
Division name
Department of Neurosurgery
Zip code
0608638
Address
North-15, West-7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL
011-706-5987
Homepage URL
masakiitou-nsu@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Clinical Research Hokkaido University Hospital
Address
North14 West5, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
016-0365
Org. issuing International ID_1
Hokkaido University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Terminated
Management information
Registered date
| 2017 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031524
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
