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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006901
Receipt No. R000008155
Scientific Title The study for mechanism of optic neuropathy evoked by aquaporin 4 antibody
Date of disclosure of the study information 2012/04/01
Last modified on 2019/06/23

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Basic information
Public title The study for mechanism of optic neuropathy evoked by aquaporin 4 antibody
Acronym The study for optic neuropathy evoked by aquaporin 4 antibody
Scientific Title The study for mechanism of optic neuropathy evoked by aquaporin 4 antibody
Scientific Title:Acronym The study for optic neuropathy evoked by aquaporin 4 antibody
Region
Japan

Condition
Condition optic neuromyelitis
Healthy volunteer
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the mechanism of optic neuritis by anti-aquaporin 4 antibody
Basic objectives2 Others
Basic objectives -Others to evaluate the presence/absence of antibodies in blood sera
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the reactivities of the blood sera from the patients or healthy volunteers against optic nerve
Key secondary outcomes the changes of retinal structure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Sampling of blood
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria patients suspected for optic neuromyelitis and healthy volunteers
Key exclusion criteria patients or volunteers who disagreed with participating in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akiyasu
Middle name
Last name Kanamori
Organization Kobe University Graduated School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code 6510017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 07838251111
Email ganka@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Akiyasu
Middle name
Last name Kanamori
Organization Kobe University Graduated School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code 6510017
Address 7-5-1,Kusunoki-cho,Chuo-ku,Kobe
TEL 07838251111
Homepage URL
Email ganka@med.kobe-u.ac.jp

Sponsor
Institute Department of Surgery, Division of Ophthalmology,Kobe University Graduated School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Neurology, Tohoku University Graduated School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe university
Address kusunokicho, tyuoku, Kobe
Tel 0783826048
Email kanaaki@med.kobe-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

Other administrative information
Date of disclosure of the study information
2012 Year 04 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
2012 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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

Management information
Registered date
2011 Year 12 Month 17 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008155

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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