UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042192 |
|---|---|
| Receipt number | R000048153 |
| Scientific Title | Registry study on development of new diagnostic, novel treatment and prevention measures of neurological diseases |
| Date of disclosure of the study information | 2020/11/18 |
| Last modified on | 2023/04/27 10:16:55 |
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Basic information
Public title
Registry study on development of new diagnostic, novel treatment and prevention measures of neurological diseases
Acronym
Neurological diseases registry
Scientific Title
Registry study on development of new diagnostic, novel treatment and prevention measures of neurological diseases
Scientific Title:Acronym
Neurological diseases registry
Region
| Japan |
Condition
Condition
Neurological diseases
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We aim to accumulate clinical information and biological sample of patients with neurological diseases and to examine evaluation items on a sustainable as well as long-standing neurological diseases registry. We also aim to clarify natural history and prognostic factors to develop new diagnostic, novel treatment and prevention measures of neurological diseases.
Basic objectives2
Others
Basic objectives -Others
Registry study (Prospective cohort study, Retrospective cohort study, Cross-sectional study)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality
Severity classification
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke, Neuroimmune disease, Infectious diseases of the nervous system, Functional neurological disorder, Neurodegenerative disease, Other neurological diseases
1) Patients who were diagnosed with the above diseases
2)Patients signed the informed consent document
Key exclusion criteria
Patients judged inappropriate for this study as judged by the investigator.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Yamano |
Organization
St. Marianna University School of Medicine
Division name
Department of Neurology
Zip code
216-8511
Address
Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL
044-977-8111
yyamano@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Yamano |
Organization
St. Marianna University School of Medicine
Division name
Department of Neurology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
yyamano@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine, Ethics Committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
0449778111
k-sienbu.mail@marianna-u.ac.jp
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
| 2020 | Year | 11 | Month | 18 | 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
688
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2040 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registry study
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048153
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
