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

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 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


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

Value
https://center6.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