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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018993
Receipt No. R000021967
Scientific Title Development of an ex vivo method for evaluation of the mitochondrial function
Date of disclosure of the study information 2015/10/19
Last modified on 2020/10/01

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Basic information
Public title Development of an ex vivo method for evaluation of the mitochondrial function
Acronym An ex vivo evaluation method for mitochondria
Scientific Title Development of an ex vivo method for evaluation of the mitochondrial function
Scientific Title:Acronym An ex vivo evaluation method for mitochondria
Region
Japan

Condition
Condition MELAS
Classification by specialty
Medicine in general Neurology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To develop a novel biomarker of MELAS
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Confirming the specificity and sensitivity of the novel biomarker for the disease activities of MELAS, compared to those of the canonical biomarker, serum lactate or the ratio of lactate/pyruvate
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Blood sampling to detect the disease-activity of MELAS
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
10 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Typical clinical picture of MELAS (myopathy, encephalopathy, lactic acidosis, and stroke-like episodes) with the specific muscle histology (RRF, SSV) and the gene alterations of mitochondrial DNA (A3243G)
Key exclusion criteria None
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Sunada
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki, Okayama, 701-0192
TEL 086-462-1111
Email ysunada@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Sunada
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki, Okayama, 701-0192
TEL 086-462-1111
Homepage URL
Email ysunada@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 19 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
2015 Year 09 Month 12 Day
Date of IRB
2015 Year 10 Month 29 Day
Anticipated trial start date
2015 Year 10 Month 19 Day
Last follow-up date
2022 Year 10 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 12 Day
Last modified on
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021967

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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