UMIN-CTR Clinical Trial

Basic information
Public title	A prospective comparative study on proteins regulating glial activation in cerebrospinal fluid of patients with neurodegenerative diseases.
Acronym	A comparative study on proteins regulating glial activation in cerebrospinal fluid of patients with neurodegenerative diseases.
Scientific Title	A prospective comparative study on proteins regulating glial activation in cerebrospinal fluid of patients with neurodegenerative diseases.
Scientific Title:Acronym	A comparative study on proteins regulating glial activation in cerebrospinal fluid of patients with neurodegenerative diseases.
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 diagnostic marker of neurodegenerative diseases including amyotrophic lateral sclerosis (ALS).
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The protein levels in cerebrospinal fluid at diagnosis.
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. ALS group Patients who is diagnosed ALS in accordance with El Escorial classification. 2. Neurodegenerative diseases group Patients who is diagnosed neurodegenerative diseases with parkinsonism (Parkinson's disease, progressive supra nuclear palsy, corticobasal syndrome, multiple system atrophy). 3. Inflammatory neurological diseases including neuromyelitis optica or multiple sclerosis. 4. Patients who was performed lumbar puncture for diagnosis and the neurological diseases with extensive gliosis were excluded.
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	110

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	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is based on the results of previous study, UMIN000030060.

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/icdr_e/ctr_view.cgi?recptno=R000041356