UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017795 |
|---|---|
| Receipt number | R000020614 |
| Scientific Title | The effects of body fluid biomarkers on neuropsychiatric disease |
| Date of disclosure of the study information | 2015/06/03 |
| Last modified on | 2015/12/04 09:09:30 |
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Basic information
Public title
The effects of body fluid biomarkers on neuropsychiatric disease
Acronym
Body fluid biomarkers in neuropsychiatric disease
Scientific Title
The effects of body fluid biomarkers on neuropsychiatric disease
Scientific Title:Acronym
Body fluid biomarkers in neuropsychiatric disease
Region
| Japan |
Condition
Condition
Neuropsychiatric disease (mainly dementia)
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to make our study including PET imaging analysis precisely by launching the assessment of body fluid biomarkers. Moreover, the secondary purpose is to find more clinically useful biomarker in cerebrospinal fluid or blood.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association of the biomarkers observed in cerebrospinal fluid/blood with their clinical data and imaging data.
Key secondary outcomes
The clinical impact of the candidate biomarkers on the diagnosis of the neuropsychiatric disease.
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
Disease subjects: patients with neuropsychiatric disease (mainly dementia, e.g. Alzheimer's disease and Parkinson's disease with dementia).
Controls: cognitively normal subjects.
Key exclusion criteria
Only the subjects in the neuroimaging study of PET/MRI/CT are included.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shimada |
Organization
National Institute of Radiological Science, Molecular Neuroimaging Center
Division name
Molecular Neuroimaging Program
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba, Japan
TEL
043-206-3251
shimada@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shimada |
Organization
National Institute of Radiological Science, Molecular Neuroimaging Center
Division name
Molecular Neuroimaging Program
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba, Japan
TEL
043-206-3251
Homepage URL
shimada@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Science, Molecular Neuroimaging Center
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Science
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
| 2015 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Method: during the visit for the examinations including PET scan, other blood (< 30 ml) or cerebrospinal fluid (< 15 ml) will be sampled for the assessment of candidate biomarkers. The genome DNA, cerebrospinal fluid, blood plasma, serum, and others are examined at Brain Research Institute, University of Niigata, and Institute of Physical and Chemical Research, if approved. Moreover, the bio-samples are going to be stored mainly in Brain Research Institute, Niigata. All the data are going to be shared for analysis using clinical parameters, psychometric tests, and neuroimaging.
Management information
Registered date
| 2015 | Year | 06 | Month | 03 | Day |
Last modified on
| 2015 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020614
