UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032873 |
|---|---|
| Receipt number | R000024176 |
| Scientific Title | Establishment of a novel biomarker of skeletal and cardiac muscle diseases |
| Date of disclosure of the study information | 2018/06/05 |
| Last modified on | 2024/03/15 09:53:46 |
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Basic information
Public title
Establishment of a novel biomarker of skeletal and cardiac muscle diseases
Acronym
A novel biomarker of skeletal and cardiac muscle diseases
Scientific Title
Establishment of a novel biomarker of skeletal and cardiac muscle diseases
Scientific Title:Acronym
A novel biomarker of skeletal and cardiac muscle diseases
Region
| Japan |
Condition
Condition
Skeletal and cardiac muscle diseases
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a vitro diagnostic pharmaceuticals, including an optimal ELISA for measuring a novel biomarker of skeletal and cardiac muscle diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Definition of a cutoff values of a novel biomarker in an optimal ELISA
Key secondary outcomes
Characterization of skeletal and cardiac muscle diseases by the novel biomarker using the optimal ELISA
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suffering skeletal and cardiac muscle diseases, and normal control subjects
Key exclusion criteria
No severe medical conditions, including stroke, diabetes, chronic liver disease, and chronic kidney diease
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Ohsawa |
Organization
Kawasaki Medical School
Division name
Neurology
Zip code
701-0114
Address
577 Matsushima,Kurashiki,Okayama 701-0192 Japan
TEL
+81-86-462-1111
yosawa@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Ohsawa |
Organization
Kawasaki Medical School
Division name
Neurology
Zip code
701-0114
Address
577 Matsushima,Kurashiki,Okayama 701-0192 Japan
TEL
+81-86-462-1111
Homepage URL
yosawa@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima,Kurashiki,Okayama 701-0192 Japan
Tel
+81-86-462-1111
kmsrec@med.kawasaki-m.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
| 2018 | Year | 06 | Month | 05 | 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 | 02 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of the vales of the novel biomarker
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024176
