UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006221 |
|---|---|
| Receipt number | R000007301 |
| Scientific Title | Clinicopathological study of neuro-glial damage biomarkers in central nervous system diseases |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2015/02/24 10:20:09 |
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Basic information
Public title
Clinicopathological study of neuro-glial damage biomarkers in central nervous system diseases
Acronym
Biomarker study of the CNS diseases
Scientific Title
Clinicopathological study of neuro-glial damage biomarkers in central nervous system diseases
Scientific Title:Acronym
Biomarker study of the CNS diseases
Region
| Japan |
Condition
Condition
Multiple Sclerosis and allied disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective study of glial markers in the diagnosis and the prognosis in multiple sclerosis and alliged disorders
Basic objectives2
Others
Basic objectives -Others
Neuromyelitis optica (NMO) is thought as an autoimmune disease against aquaporin 4, predominantly localized in astrocytic foot processes. We showed that the staining of glial fibrillary acidic protein (GFAP) was lost in the NMO lesions lacking AQP4 immunoreactivity and we could see the marked damaging value in cerebrospinal fluid GFAP assay. Recently, in NMO as well as multiple sclerosis (MS), the astrocyte is considered as a key component in demyelinating processes. However, there is no adequate study to reveal the astrocyte damage in heterogeneous demyelinating diseases.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This study will bring us the promising tool in making dianogosis or therapeutic strategy in demyelinating diseases including multiple sclerosis and neuromyelitis optica
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
| Other |
Interventions/Control_1
To test a serum and cerebrospinal fluid level of glial and other biomarkers, and to observe the diagnotic or prognostic value of the diseases
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
| 15 | years-old | < |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with multiple sclerosis and alliged disorders, who had received lumbar puncture for the diagnosis and agreed to the informed consent.
Key exclusion criteria
Patients who will not agree to the study design.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MISU Tatsuro |
Organization
Tohoku University Graduate School of Medicine
Division name
Multiple Scleorosis Therapeutics
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai 980-8574, Japan
TEL
81-22-717-7189
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Graduate School of Medicine
Division name
Neurology
Zip code
Address
1-1Seiryomachi, Aobaku, Sendai 980-8574, Japan
TEL
Homepage URL
Sponsor or person
Institute
Multiple Sclerosis Therapeutics, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2011 | Year | 09 | 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
| 2011 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 24 | 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 | 08 | Month | 23 | Day |
Last modified on
| 2015 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007301
