UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034525 |
|---|---|
| Receipt number | 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 | 2023/04/20 09:15:17 |
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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 | Makoto |
| Middle name | |
| Last name | Urushitani |
Organization
Shiga University of Medical Science
Division name
Department of Neurology
Zip code
5202192
Address
Seta-Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2160
hqsinkei@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Urushitani |
Organization
Shiga University of Medical Science
Division name
Department of Neurology
Zip code
5202192
Address
Seta-Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2160
Homepage URL
hqsinkei@belle.shiga-med.ac.jp
Sponsor or person
Institute
KAN research institute
Institute
Department
Personal name
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
Center for Clinical Research
Address
00
Tel
0775482111
hqchiken@belle.shiga-med.ac.jp
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
27
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039364
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
