UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030060 |
|---|---|
| Receipt number | R000033294 |
| Scientific Title | Study of proteins modulating gliosis in cerebrospinal fluid in neurodegenerative diseases |
| Date of disclosure of the study information | 2017/11/21 |
| Last modified on | 2018/06/08 14:02:36 |
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Basic information
Public title
Study of proteins modulating gliosis in cerebrospinal fluid in neurodegenerative diseases
Acronym
Study of proteins modulating gliosis in neurodegenerative diseases
Scientific Title
Study of proteins modulating gliosis in cerebrospinal fluid in neurodegenerative diseases
Scientific Title:Acronym
Study of proteins modulating gliosis in neurodegenerative diseases
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis (ALS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the changes of proteins modulating gliosis in cerebrospinal fluid (CSF) in neurodegenerative diseases and to develop new biomarkers for neurodegenerative diseases
Basic objectives2
Others
Basic objectives -Others
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive motor neuron death accompanied by excessive gliosis in spinal ventral horn.
Increased astrocytes and microglia in neurodegenerative disease are considered to be harmful to neurons.
However, little is known about mechanism of gliosis.
We have detected a protein that promotes astrocytosis in CSF of ALS model rats.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantification of gliosis-moderating proteins in CSF from ALS patients using enzyme-linked immunosorbent assay (ELISA)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Sporadic ALS
ALS patients diagnosed as "clinically probable laboratory supported", "clinically probable" or "clinically definite" with El Escorial revised diagnostic criteria (WFN)
2. SOD1-linked ALS
ALS patients with SOD1 mutation
3. Control
other neurological diseases
Key exclusion criteria
Patients with a history of intrathecal infection
Patients with a history of intrathecal drug administration
Patients with a history of spine or spinal cord surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Warita |
Organization
Tohoku University Hospital
Division name
Department of Neurology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7189
warita-ns@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Shijo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7189
Homepage URL
shijo-t@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 11 | Month | 21 | 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
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
a
Management information
Registered date
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033294
