UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051577 |
|---|---|
| Receipt number | R000058848 |
| Scientific Title | An Exploratory Study of New Biomarkers through the Analysis of Liver Repair Mechanisms |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/11 12:50:25 |
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Basic information
Public title
Establishment of Rehabilitation Medicine for Muscle Regeneration in Cirrhosis of the Liver An Exploratory Study of New Biomarkers through the Analysis of Liver Repair Mechanisms
Acronym
Rehabilitation Medicine in Liver Cirrhosis
Scientific Title
An Exploratory Study of New Biomarkers through the Analysis of Liver Repair Mechanisms
Scientific Title:Acronym
Exploratory Study of New Biomarkers
Region
| Japan |
Condition
Condition
Patients with liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to examine the effect of exercise therapy on liver fibrosis, regeneration, and improvement of liver function with cirrhosis and comprehensively analyze myokines and extracellular vesicles in the blood during therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To establish a standardized clinical exercise therapy, we will first create a standard muscle attenuation curve over time for patients with cirrhosis based on past clinical data from each institution.
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
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise recommendations at home with a Borg index around ten
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with liver disease of Child A-B and PS0
Key exclusion criteria
Massive ascites, untreated esophageal varices, PS3-4
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Terai |
Organization
Graduate School of Medical and Dental Sciences
Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
951-8510
Address
Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
0252272207
hiroteruk@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroteru |
| Middle name | |
| Last name | Kamimura |
Organization
Graduate School of Medical and Dental Sciences Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
9518510
Address
Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
0252272207
Homepage URL
hiroteruk@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
hiroteru kamimura
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japam
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Niigata University School of Medicine
Address
Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
Tel
0252272625
hiroteruk@med.niigata-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
| 2023 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058848
| 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 |
