UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018107 |
|---|---|
| Receipt number | R000020962 |
| Scientific Title | Immunological analysis of neuromyelitis optica. |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2015/06/26 20:11:25 |
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Basic information
Public title
Immunological analysis of neuromyelitis optica.
Acronym
Immunological analysis of neuromyelitis optica.
Scientific Title
Immunological analysis of neuromyelitis optica.
Scientific Title:Acronym
Immunological analysis of neuromyelitis optica.
Region
| Japan |
Condition
Condition
Neuromyelitis optica spectrum disorder
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to analyze peripheral blood lymphocyte subsets in patients with NMO.
Basic objectives2
Others
Basic objectives -Others
To elucidate the analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The QOSI score, the ratio of each lymphocyte subset, autoantibody titer.
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Vein drawing 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The NMO patient
Key exclusion criteria
The patient who refused this reseach
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Tanaka |
Organization
Saitama medical center, Saitama medical university
Division name
Neurology
Zip code
Address
1981 Kamoda, Kawagoe, SAITAMA
TEL
049-228-3400
satoru_t@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Tanaka |
Organization
Saitama medical center, Saitama medical university
Division name
Neurology
Zip code
Address
1981 Kamoda, Kawagoe, SAITAMA
TEL
049-228-3400
Homepage URL
satoru_t@saitama-med.ac.jp
Sponsor or person
Institute
Neurology, Saitama medical center, Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 16 | 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
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2015 | 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=R000020962
