UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018993 |
|---|---|
| Receipt number | 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 10:12:50 |
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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
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
ysunada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021967
| Research Plan | |
|---|---|
| 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 |
