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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036298
Receipt No. R000041333
Scientific Title A cohort study on proteins regulating glial activation in cerebrospinal fluid of patients with amyotrophic lateral sclerosis.
Date of disclosure of the study information 2019/06/01
Last modified on 2019/10/07

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Basic information
Public title A cohort study on proteins regulating glial activation in cerebrospinal fluid of patients with amyotrophic lateral sclerosis.
Acronym A cohort study on proteins regulating glial activation in cerebrospinal fluid of patients with amyotrophic lateral sclerosis.
Scientific Title A cohort study on proteins regulating glial activation in cerebrospinal fluid of patients with amyotrophic lateral sclerosis.
Scientific Title:Acronym A cohort study on proteins regulating glial activation in cerebrospinal fluid of patients with amyotrophic lateral sclerosis.
Region
Japan

Condition
Condition amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a new surrogate marker which evaluates disease progression of amyotrophic lateral sclerosis (ALS).
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the protein levels in cerebrospinal fluid between at-diagnosis and 10-months post diagnosis.
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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Sample both the cerebrospinal fluid and peripheral blood twice.
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 Patients who is diagnosed ALS in accordance with El Escorial classification.
Key exclusion criteria Patients with a history of cerebrospinal cavity infection
Patients with a history of intrathecal administration
Patients with a surgery of spine or spinal cord
Patients who were decided to be inappropriate by the researchers
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Warita
Organization Tohoku University Hospital
Division name Department of Neurology
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7189
Email warita-ns@umin.net

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Shijo
Organization Tohoku University Hospital
Division name Department of Neurology
Zip code 980-8574
Address 1-1 Seiryo-machi, 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 Department of Neurology, Tohoku University Hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel 022-717-7189
Email warita-ns@umin.net

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
2019 Year 06 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 26 Day
Date of IRB
2019 Year 05 Month 22 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 26 Day
Last modified on
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041333

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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