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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015133
Receipt No. R000017525
Scientific Title Development of novel biomarkers of neurodegenerative diseases-comprehensive analysis of the proteins and the RNAs in exosomes extracted from cerebrospinal fluid and urine
Date of disclosure of the study information 2014/09/12
Last modified on 2014/09/16

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Basic information
Public title Development of novel biomarkers of neurodegenerative diseases-comprehensive analysis of the proteins and the RNAs in exosomes extracted from cerebrospinal fluid and urine
Acronym Development of novel biomarkers in exosomes extracted from cerebrospinal fluid and urine
Scientific Title Development of novel biomarkers of neurodegenerative diseases-comprehensive analysis of the proteins and the RNAs in exosomes extracted from cerebrospinal fluid and urine
Scientific Title:Acronym Development of novel biomarkers in exosomes extracted from cerebrospinal fluid and urine
Region
Japan

Condition
Condition Neurodegenerative diseases including amyotrophic lateral sclerosis, Parkinson disease, multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of novel biomarkers of neurodegenerative diseases
Basic objectives2 Others
Basic objectives -Others Our purpose is to develop novel biomarkers of neurodegenerative disease through comprehensive analysis of the proteins and the RNAs of exosomes extracted from cerebrospinal fluid and urine
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Identification of novel biomarkers
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Examination of cerebrospinal fluid and urine will be conducted, but no interventions are planned.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects are the patients having neurodegenerative diseases (such as amyotrophic lateral sclerosis, Parkinson disease, multiple system atrophy, progressive supranuclear palsy or corticobasal syndrome) and other diseases, who are required to have examination of cereblospinal fluid and urine. 20 patients of each neurodegenerative disease and 30 patients with other disease will be attended.
Key exclusion criteria The participants are not limited by the age or gender.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Doi
Organization Yokohama City University
Division name Department of Neurology and Stroke Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2511
Email doi@rkd.d-bs.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Doi
Organization Yokohama City University
Division name Department of Neurology and Stroke Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2511
Homepage URL
Email doi@rkd.d-bs.com

Sponsor
Institute Department of Neurology and Stroke Medicine, Yokohama City University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Creation of Innovation Centers for
Advanced Interdisciplinary Research Areas Program, MEXT Japan
Establishment of Research Center for Clinical Proteomics of Post-translational Modifications
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 横浜市立大学神経内科学・脳卒中医学

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 12 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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2014 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017525


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