UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062415 |
|---|---|
| Receipt number | R000071426 |
| Scientific Title | Multicenter retrospective cohort study of the association between body composition, handgrip strength, and prognosis in patients with cirrhosis |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/30 22:49:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of muscle, fat, handgrip strength, and health outcomes in patients with cirrhosis
Acronym
Cirrhosis body composition study
Scientific Title
Multicenter retrospective cohort study of the association between body composition, handgrip strength, and prognosis in patients with cirrhosis
Scientific Title:Acronym
Body composition and prognosis cohort Study in patients with cirrhosis
Region
| Japan |
Condition
Condition
Cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the sex-specific impact of body composition and handgrip strength on prognosis in patients with liver cirrhosis. Specifically, visceral adipose tissue, subcutaneous adipose tissue, handgrip strength, and skeletal muscle mass will be analyzed as continuous variables, and restricted cubic spline (RCS) analysis will be used to characterize nonlinear associations with prognosis in each sex.
Basic objectives2
Others
Basic objectives -Others
Sex-specific prognostic risk assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Liver-related death and non-liver-related death
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with liver cirrhosis who had available data on body composition assessed at the third lumbar vertebra (L3) level using abdominal CT and handgrip strength, and who had at least 1 year of follow-up after the body composition assessment.
Key exclusion criteria
Patients with malignant tumors, including hepatocellular carcinoma, at the time of body composition assessment (baseline).
Patients with renal failure or poorly controlled cardiac or respiratory disease at the time of body composition assessment (baseline).
Patients with missing data required for the analysis.
Patients who declined participation in the study through the opt-out process.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kakisaka |
Organization
Iwate Medical University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
028-3695
Address
Idaidori 2-1-1, Yahaba, Iwate
TEL
019-613-7111
keikaki@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Endo |
Organization
Iwate Medical University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
028-3695
Address
Idaidori 2-1-1, Yahaba, Iwate
TEL
019-613-7111
Homepage URL
keiendo@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastroenterology, Gifu University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Iwate Medical University Hospital
Address
Idaidori 2-1-1, Yahaba, Iwate
Tel
019-613-7111
kenkyu-rinri@j.iwate-med.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
岩手医科大学付属病院
岐阜大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | 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
700
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective observational study. Patients with liver cirrhosis who visited the participating institutions between January 1, 2011, and December 31, 2025, will be included. The associations between prognosis and body composition assessed at the third lumbar vertebra (L3) level on abdominal CT (skeletal muscle mass, subcutaneous adipose tissue, and visceral adipose tissue) as well as handgrip strength will be analyzed. No intervention will be performed, and the study will use existing clinical data only.
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071426
