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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032873
Receipt No. R000024176
Official scientific title of the study Establishment of a novel biomarker of skeletal and cardiac muscle diseases
Date of disclosure of the study information 2018/06/05
Last modified on 2018/06/05

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Basic information
Official scientific title of the study Establishment of a novel biomarker of skeletal and cardiac muscle diseases
Title of the study (Brief title) 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 Yutaka Ohsawa
Organization Kawasaki Medical School
Division name Neurology
Address 577 Matsushima,Kurashiki,Okayama 701-0192 Japan
TEL +81-86-462-1111
Email yosawa@med.kawasaki-m.ac.jp

Public contact
Name of contact person Yutaka Ohsawa
Organization Kawasaki Medical School
Division name Neurology
Address 577 Matsushima,Kurashiki,Okayama 701-0192 Japan
TEL +81-86-462-1111
Homepage URL
Email yosawa@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 02 Month 09 Day
Anticipated trial start date
2016 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Observation of the vales of the novel biomarker

Management information
Registered date
2018 Year 06 Month 05 Day
Last modified on
2018 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024176

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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