UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036299 |
|---|---|
| Receipt number | R000041356 |
| Scientific Title | A prospective comparative study on proteins regulating glial activation in cerebrospinal fluid of patients with neurodegenerative diseases. |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/10/07 14:36:33 |
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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
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
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
Department of Neurology, Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-7189
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041356
