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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034525
Receipt No. R000039364
Scientific Title Identification of diagnostic and progression biomarkers of neurodegenerative diseases
Date of disclosure of the study information 2018/10/16
Last modified on 2018/10/16

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Basic information
Public title Identification of diagnostic and progression biomarkers of neurodegenerative diseases
Acronym Biomarkers for neurodegenerative diseases
Scientific Title Identification of diagnostic and progression biomarkers of neurodegenerative diseases
Scientific Title:Acronym Biomarkers for neurodegenerative diseases
Region
Japan

Condition
Condition ALS, Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, multisystem atrophy, spinocerebellar degeneration
Classification by specialty
Neurology Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comprehensive screening for diagnostic or prognostic biomarkers for neurodegenerative diseases
Basic objectives2 Others
Basic objectives -Others develop diagnostic and pharmacokinetic markers.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes lymphocyte subset, immunophenotype,
Key secondary outcomes NF-H, NF-L, inflammatory markers, chromogranins (A, B), carbonylated proteins

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients admitted to Shiga University hospital, Neurology department, with the suspected diagnosis of the following diseases;
ALS, Parkinson's disease, PSP, CBS, MSA(including SCD), cerebral infarction, normal pressure hydrocephalus, inflammatory neuropathy.
Key exclusion criteria Any person under 16 years old.
Pregnant patients.
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Urushitani
Organization Shiga University of Medical Science
Division name Department of Neurology
Zip code
Address Seta-Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2160
Email hqsinkei@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Urushitani
Organization Shiga University of Medical Science
Division name Department of Neurology
Zip code
Address Seta-Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2160
Homepage URL
Email hqsinkei@belle.shiga-med.ac.jp

Sponsor
Institute KAN research institute
Institute
Department

Funding Source
Organization KAN research institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Neurology, Kyoto Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1 REP-2017-0430-011-E
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 滋賀医科大学、カン研究所

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 16 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
2016 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients after acceptance of the informed consent, a part of the blood or cerebrospinal fluid obtained for clinical use, will be processed for biomarker study. In ALS patients, blood sampling will be followed every three months.

Management information
Registered date
2018 Year 10 Month 16 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039364

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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