UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060977 |
|---|---|
| Receipt number | R000069255 |
| Scientific Title | Non-Invasive Diagnosis and Prognostic Modeling Study in Steatotic Liver Disease in JAPAN |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/18 20:52:33 |
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Basic information
Public title
Development of a Non-Invasive Diagnostic Algorithm and Prognostic Prediction Model for Steatotic Liver Disease in JAPAN:
A Multicenter Retrospective Large-Scale Database Study
Acronym
A Multicenter Study Using Non-Invasive Tests to Predict Long-Term Outcomes in Fatty Liver Disease in JAPAN
Scientific Title
Non-Invasive Diagnosis and Prognostic Modeling Study in Steatotic Liver Disease in JAPAN
Scientific Title:Acronym
SLD-NILDA JAPAN Study
Region
| Japan |
Condition
Condition
Patients with Steatotic Liver Disease(SLD)
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to establish a large-scale NILDA database in patients with steatotic liver disease (SLD) by integrating patient demographics, laboratory findings, and histopathological assessments. Using this database as a foundation, we aim to comprehensively re-evaluate non-invasive diagnostic algorithms for SLD and to develop prognostic prediction models for overall survival through multifaceted analyses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis of Steatotic Liver Disease Using the NILDA Database
Key secondary outcomes
1) To develop predictive models for the progression of liver injury and hepatocarcinogenesis in patients with steatotic liver disease (SLD) using the NILDA database.
2) To evaluate the diagnostic performance of NILDA for liver fibrosis and to determine optimal cutoff values, using liver biopsy and magnetic resonance elastography (MRE) as reference standards.
3) To evaluate the diagnostic performance of NILDA for hepatic steatosis and to determine optimal cutoff values, using liver biopsy and magnetic resonance imaging-proton density fat fraction (MRI-PDFF) as reference standards.
4) To develop a predictive model for identifying patients with high-risk metabolic dysfunction-associated steatohepatitis (MASH), defined as a NAFLD activity score >=4 and liver fibrosis stage >=2.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with SLD or suspected SLD
Definition of suspected SLD: patients meeting at least one of the following criteria
Patients with cardiometabolic risk factors
Patients with liver function abnormalities
Key exclusion criteria
1) Patients deemed ineligible by the attending physician
2) Patients who have declined participation following public disclosure of the study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kuroda |
| Middle name | |
| Last name | Hidekatsu |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
hikuro@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Abe |
| Middle name | |
| Last name | Tamami |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
Homepage URL
mokosantokosan@yahoo.co.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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
| 2026 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | 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
N/A
Management information
Registered date
| 2026 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069255
