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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029195
Receipt No. 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 2017/09/19

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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
0 years-old <=
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
Middle name
Last name Kiyohiro Houkin
Organization Hokkaido University Hospital
Division name Department of Neurosurgery
Zip code
Address North-15, West-7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL 011-706-5987
Email houkin@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Kazumata
Organization Hokkaido University Hospital
Division name Department of Neurosurgery
Zip code
Address North-15, West-7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL 011-706-5987
Homepage URL
Email kazumata@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruiting participants

Management information
Registered date
2017 Year 09 Month 19 Day
Last modified on
2017 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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