UMIN-CTR Clinical Trial

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
Email	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
Email	masakiitou-nsu@umin.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	Ethical Review Board for Clinical Research Hokkaido University Hospital
Address	North14 West5, Sapporo, Japan
Tel	011-706-7636
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031524