UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023962 |
|---|---|
| Receipt number | R000027510 |
| Scientific Title | Efficacy of the criterion of sarcopenia in chronic liver disease |
| Date of disclosure of the study information | 2016/09/06 |
| Last modified on | 2021/07/20 20:01:34 |
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Basic information
Public title
Efficacy of the criterion of sarcopenia in chronic liver disease
Acronym
Sarcopenia in chronic liver disease
Scientific Title
Efficacy of the criterion of sarcopenia in chronic liver disease
Scientific Title:Acronym
Sarcopenia in chronic liver disease
Region
| Japan |
Condition
Condition
Chronic liver disesase
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the criterion of the sarcopenia in chronic liver disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the survival span of patient with sarcopenia and non-sarcopenia
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) chronic liver disease
2) Cases obtained written informed consent
Key exclusion criteria
1) Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Uojima |
| Middle name | |
| Last name | Haruki |
Organization
Kitasato University school of medicine
Division name
Department of Gastroenterology
Zip code
252-0375
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
kiruha555@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0375
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
Homepage URL
kiruha555@yahoo.co.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato institute hospital research ethics committee
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel
+81-42-778-8111
mailtorinri@med.kitasato-u.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
| 2016 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The new JSH criteria for sarcopenia are accurate predictors of poor prognosis in patients with liver cirrhosis.
Management information
Registered date
| 2016 | Year | 09 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027510
| 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 |
