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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030060
Receipt No. 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

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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
Email 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
Email shijo-t@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033294

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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