UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006901 |
|---|---|
| Receipt number | 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 | 2024/06/26 19:34:29 |
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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
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
ganka@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Division of Ophthalmology,Kobe University Graduated School of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
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
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008155
