Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060977) titled 'Development of a Non-Invasive Diagnostic Algorithm and Prognostic Prediction Model for Steatotic Liver Disease in JAPAN:
A Multicenter Retrospective Large-Scale Database Study' on March 31.
Study Type:
Observational
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Patients with Steatotic Liver Disease(SLD)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 2000
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069255
Disclaimer: Curated by HT Syndication.
