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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038398
Receipt No. R000043756
Scientific Title Research for biomarkers in patients with rapidly progressive dementia including human prion disease
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/27

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

Condition
Condition rapidly progressive dementia including human prion disease
Classification by specialty
Neurology Infectious disease 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 Explanatory
Developmental phase Not applicable

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 500 cases per one year
2500 cases forfive years
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 2500

Research contact person
Name of lead principal investigator
1st name Katsuya
Middle name
Last name Satoh
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki City, Japan
TEL 095-819-7991
Email satoh-prion@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Katsuya
Middle name
Last name Satoh
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki City, Japan
TEL 095-819-7991
Homepage URL http://www2.am.nagasaki-u.ac.jp/prion-cjd/prion/
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 Japan

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

IRB Contact (For public release)
Organization Nagasaki University Life and Medical Sciences, Research Office, General Affairs Division (Research Support)
Address 1-12-4 Sakamoto, Nagasaki City
Tel 095-819-7198
Email yoshi-t@nagasaki-u.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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 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
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
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 01 Day
Anticipated trial start date
2019 Year 10 Month 25 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
2024 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 27 Day
Last modified on
2019 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043756

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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