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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011822
Receipt No. R000013817
Scientific Title Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Date of disclosure of the study information 2013/10/01
Last modified on 2020/09/25

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Basic information
Public title Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Acronym Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Scientific Title Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Scientific Title:Acronym Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Region
Japan

Condition
Condition Neuromyelitis Optica (NMO)
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine MR findings of the optic nerves, spinal cord, and brain in NMO patients and determine the characteristic features of NMO by comparing them with MR findings of the optic nerves, spinal cord, and brain in MS patients.
Basic objectives2 Others
Basic objectives -Others Contribution to the differential diagnosis of NMO and MS
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Descriptive assessments of lesions in the optic nerves, spinal cord, and brain in terms of distribution, frequency, and nature in the NMO group and in the MS group.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria NMO (including NMO spectrum disorder) and MS patients who underwent MRI examination(>1.5T) from April 1,2008 by March 31, 2013
Key exclusion criteria Patients judged by the (sub-) investigator to be ineligible as a study subject
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Miki
Organization Osaka City University
Division name Radiology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka ,545-0051, JAPAN
TEL 06-6645-3831
Email yukio.miki@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Miki
Organization Osaka City University
Division name Radiology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka ,545-0051, JAPAN
TEL 06-6645-3831
Homepage URL
Email yukio.miki@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Bayer Yakuhin, Inc.
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
Address
Tel
Email

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
2013 Year 10 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 Completed
Date of protocol fixation
2013 Year 04 Month 04 Day
Date of IRB
2015 Year 07 Month 28 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NMO is relatively prevalent in East Asia, including Japan, and magnetic resonance (MR) findings of NMO have been reported in Japan and South Korea. However, almost all reports thus far published are nothing but compilations of a relatively small number of cases at a single center.

Management information
Registered date
2013 Year 09 Month 20 Day
Last modified on
2020 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013817

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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