UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062014 |
|---|---|
| Receipt number | R000070963 |
| Scientific Title | CLIONE study |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 19:26:32 |
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Basic information
Public title
A Multicenter Study of Liver Health and Extrahepatic Diseases in Patients with MASLD
Acronym
CLIONE study
Scientific Title
CLIONE study
Scientific Title:Acronym
A Multicenter Study of the Epidemiology of Hepatic Histopathology and Extrahepatic Comorbidities in Patients with Fatty Liver Disease Who Underwent Liver Biopsy
Region
| Japan |
Condition
Condition
Steatotic liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the impact of comorbidities and their treatments on survival outcomes in patients with steatotic liver disease
Basic objectives2
Others
Basic objectives -Others
To investigate the associations between the prognosis of steatotic liver disease (SLD) and findings from liver fibrosis biomarkers, circulating metabolites, and artificial intelligence (AI)-based analyses of histopathological features.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate mortality in patients with steatotic liver disease according to the presence of extrahepatic comorbidities (type 2 diabetes, chronic kidney disease, and cardiovascular disease) and the use of related therapeutic medications.
Key secondary outcomes
To investigate the associations of extrahepatic comorbidities, liver-related events, and extrahepatic malignancies with patient characteristics in individuals with steatotic liver disease.
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) Patients who underwent liver biopsy between January 1, 1990 and June 30, 2025.
2) Patients aged younger than 20 years at the time of liver biopsy.
3) Patients with histologically confirmed NAFLD/MASLD.
4) Patients with metabolic dysfunction and/or obesity who did not meet the histological or clinical criteria for NAFLD/MASLD.
Key exclusion criteria
1) Patients deemed unsuitable for this study by the investigators.
2) Patients who refused to participate in the study.
3) Patients suspected of having other chronic liver diseases.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga University
Division name
Division of Metabolism and Endocrinology
Zip code
8498501
Address
Nabesima 5-1-1, Saga City
TEL
0952316511
takahas2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROKAZU |
| Middle name | |
| Last name | Takahashi |
Organization
Faculty of Medicine, Saga University
Division name
Division of Metabolism and Endocrinology
Zip code
8498501
Address
Nabesima 5-1-1, Saga City
TEL
09084095130
Homepage URL
takahas2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Hirokazu Takahashi
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Metropolitan University Graduate School of Medicine, Department of Hepatology and Gastroenterology, Asahikawa Medical University, Department of Gastroenterology and Hematology, Yokohama City University, Department of Gastroenterology and Hepatology, Okayama University, Department of Gastroenterology and Hepatology, Suita Municipal Hospital, Department of Gastroenterology, Kawasaki Medical School General Medical Center, Department of General Internal Medicine 2, JA Hiroshima General Hospital, Department of Hepatology, Shimane University Hospital, Department of Hepatology, Kagawa University, Department of Gastroenterology and Neurology, Kurume University School of Medicine, Division of Gastroenterology, Department of Medicine, Kochi University, Department of Gastroenterology and Hepatology, University of the Ryukyus, First Department of Internal Medicine, Ogaki Municipal Hospital, Department of Gastroenterology, Osaka University, Department of Medical Data Science, Gifu Municipal Hospital, Department of Gastroenterology, Hamamatsu University School of Medicine, Second Department of Internal Medicine, National Defense Medical College Hospital, Department of Gastroenterology and Hepatology, Osaka General Hospital of West Japan Railway Company, Department of Gastroenterology, Jichi Medical University, Division of Gastroenterology, Department of Internal Medicine, Kyoto Prefectural University of Medicine, Department of Gastroenterology and Hepatology, Nagoya University Hospital, Department of Gastroenterology and Hepatology, Nippon Medical School Hospital, Department of Gastroenterology and Hepatology, Hiroshima University, Liver Disease Center, Saiseikai Suita Hospital, Department of Gastroenterology, Kyushu University Graduate School of Medical Sciences, Department of Anatomic Pathology, International University of Health and Welfare Narita Hospital, Department of Palliative Medicine, Fukuoka University Faculty of Medicine, Department of Gastroenterology, Japan Medical Strategy Research Institute.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
linical Research Center, Saga University Hospital, Faculty of Medicine
Address
5-1-1 Nabeshima Saga City, Saga, Japan
Tel
0952342085
kenkyu-shinsei@ml.cc.saga-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
| 2026 | Year | 06 | Month | 22 | 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
| 2025 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 registry study investigating the prognosis of biopsy-confirmed steatotic liver disease.
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070963
