UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010883 |
|---|---|
| Receipt number | R000012636 |
| Scientific Title | Development of biomarker in neurodegenerative disease and psychiatric disorders |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2022/06/13 19:04:05 |
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Basic information
Public title
Development of biomarker in neurodegenerative disease and psychiatric disorders
Acronym
Development of biomarker in neuropsychiatric disorders
Scientific Title
Development of biomarker in neurodegenerative disease and psychiatric disorders
Scientific Title:Acronym
Development of biomarker in neuropsychiatric disorders
Region
| Japan |
Condition
Condition
Neurodegenerative disease
Psychiatric disorder
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
CRMP family protein molecule in the blood, to consider whether early can be a biomarker of neuropsychiatric disorders.
Basic objectives2
Others
Basic objectives -Others
To consider the relationship with neuropsychiatric disorders and CRMP family protein molecule.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity,Specificity,positive and negative likelihood ratios of CRMP family protein molecule in the blood for identifying neuropsychiatric disorders.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
blood test
Interventions/Control_2
cognitive test
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
neurodegenerative disease patients
psychiatric disorder patients
Key exclusion criteria
Body complications in critically ill patients
Patients who do not have a person that you can substitute the decision of the principal consent capacity, nor the person
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Goshima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Molecular Pharmacology & Neurobiology
Zip code
2360004
Address
fukuura kanazawa ward yokohama city
TEL
045-783-2594
goshima@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Munetaka |
| Middle name | |
| Last name | Nomoto |
Organization
Yokohama City University Medical Center
Division name
Department of Psychiatry
Zip code
2400026
Address
4-57 Urafunecho minami ward yokohama city kanagawa prefecture
TEL
045-261-5656
Homepage URL
munetaka@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education,culture,sports,science and technology,JAPAN
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
Yokohama City University Medical Center
Address
4-57 Urafunecho Minami ward Yokohama city Kanagawa prefecture
Tel
045-261-5656
munetaka@yokohama-cu.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
横浜市立大学医学部附属病院
横浜市立大学医学部附属 市民総合医療センター
横浜舞岡病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.pnas.org/doi/10.1073/pnas.2100032118
Number of participants that the trial has enrolled
58
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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 13 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 13 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012636
