UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021224 |
|---|---|
| Receipt number | R000024479 |
| Scientific Title | Exploratory research into biomarkes for neurodegenerative diseases in peripheral blood and cerebrospinal fluid |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2019/03/08 13:56:56 |
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Basic information
Public title
Exploratory research into biomarkes for neurodegenerative diseases in peripheral blood and cerebrospinal fluid
Acronym
Exploratory research into biomarkes for neurodegenerative diseases
Scientific Title
Exploratory research into biomarkes for neurodegenerative diseases in peripheral blood and cerebrospinal fluid
Scientific Title:Acronym
Exploratory research into biomarkes for neurodegenerative diseases
Region
| Japan |
Condition
Condition
Neurodegenerative diseases
(especially Parkinson's disease and related disorder, amyotrophic lateral sclerosis)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish biomarkers available for clinic settings
Basic objectives2
Others
Basic objectives -Others
This is not a research of drug administration
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To identify proteins that is useful for disease biomarker
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
target diseases
Key exclusion criteria
nothing particular
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Takahashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan
TEL
075-751-3111
ryosuket@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Okuda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan
TEL
075-751-3767
Homepage URL
okudas@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 29 | 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
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The targets will be elected from the patients who consult our department and are diagnosed as Parkinson's disease, related disorder and amyotrophic laterral sclerosis since April 2016 to March 2021. Their cerebrospinal fluid and peripheral blood will be analysed.
(The patients is not continuously observed.)
Management information
Registered date
| 2016 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024479
