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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003301
Receipt No. R000003962
Scientific Title Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients
Date of disclosure of the study information 2012/03/31
Last modified on 2015/03/27

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Basic information
Public title Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients
Acronym Analysis of efficacy of markers in CSFof prio disease patients
Scientific Title Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients
Scientific Title:Acronym Analysis of efficacy of markers in CSFof prio disease patients
Region
Japan

Condition
Condition prion disease
Classification by specialty
Medicine in general Neurology Infectious disease
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of biochemical makers and Usefulness of the detective method of abnormal prion protein of CSF in prion disease patients
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes the diagnostic markers of prion disease
Key secondary outcomes the sensitivity and the specificity

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 prion disease patients
Key exclusion criteria non-prion disease patients
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Satoh
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name department of Molecular Microbiology and Immunology
Zip code
Address 1-12-4 Sakamoto, Nagasaki
TEL 095-819-7059
Email f1537@cc.nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Satoh
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-12-4 Sakamoto, Nagasaki
TEL 095-819-7059
Homepage URL
Email f1537@cc.nagasaki-u.ac.jp

Sponsor
Institute Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We had analyzed for the sensitivity and specificity of biomarkers and RT-QUIC method. We are going to report them by the manuscript in 2015.  
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
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 30 Day
Date of closure to data entry
2014 Year 03 Month 30 Day
Date trial data considered complete
2014 Year 03 Month 30 Day
Date analysis concluded
2014 Year 03 Month 30 Day

Other
Other related information retrospective study to reveal the rate of biochemical marker and the usefulness of the detcteion of abnormal prion protein in CSF of prio disease patients.

Management information
Registered date
2010 Year 03 Month 08 Day
Last modified on
2015 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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