UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015133 |
|---|---|
| Receipt number | 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 07:53:15 |
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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
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
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
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
doi@rkd.d-bs.com
Sponsor or person
Institute
Department of Neurology and Stroke Medicine, Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017525
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
