UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of proteins modulating gliosis in cerebrospinal fluid in neurodegenerative diseases
Title of the study (Brief title)	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	Hitoshi Warita
Organization	Tohoku University Hospital
Division name	Department of Neurology
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	Tomomi Shijo
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033294