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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016855
Receipt No. R000018989
Scientific Title Research for biomarkers of serum/CSF in patients with rapidly progressive dementia including human prion disease
Date of disclosure of the study information 2015/04/01
Last modified on 2017/09/20

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Basic information
Public title Research for biomarkers of serum/CSF in patients with rapidly progressive dementia including human prion disease
Acronym Research for biomarkers of serum/CSF in patients with rapidly progressive dementia
Scientific Title Research for biomarkers of serum/CSF in patients with rapidly progressive dementia including human prion disease
Scientific Title:Acronym Research for biomarkers of serum/CSF in patients with rapidly progressive dementia
Region
Japan Asia(except Japan) North America
South America Australia Europe

Condition
Condition rapidly progressive dementia including human prion disease
Classification by specialty
Medicine in general Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We clarify a causative agent using living body materials for an intervital patient diagnosed as being progressive rapidly and establish the biomarker and protein detection method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The sensitivity and specificity of biomarkers among the 1500 cases during three years
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 one year 500 cases
three years 1500 cases
472 cases nominated from April 2015 to March 2016.
And 492 cases nominated from April 2016 to March 2017.
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 The cases suspected rapidly progressive dementia including prion disease
Key exclusion criteria none
Target sample size 1500

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 satoh-prion@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 Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7991
Homepage URL http://www.med.nagasaki-u.ac.jp/mmi/cmb/prion/index.html
Email satoh-prion@nagasaki-u.ac.jp

Sponsor
Institute Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Research Group on surveillance and infection prevention of prion disease
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
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 長崎県長崎市坂本1-7-1保健学科棟5階

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 12 Day
Date trial data considered complete
2018 Year 04 Month 15 Day
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 20 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018989

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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