Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease

Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease - Non-interventional Prospective Observational Study: Exploration of Long-Term Prognostic Indicators in Patients with Chronic Liver Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053108

Enrollment

3000

Registered

2023-12-19

Start date

2023-11-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with chronic liver diseases (such as viral chronic hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, primary biliary cholangitis, autoimmune hepatitis, metabolic liver diseases, congestive hepatopathy, liver tumors, etc.) who meet all the selection criteria below and do not meet any of the exclusion criteria shall be considered eligible for registration.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with chronic liver diseases at our department (including cases diagnosed with chronic liver diseases simultaneously with liver cancer)

Exclusion criteria

Exclusion criteria: Cases where consent via written documentation for research participation cannot be obtained. Cases below 20 years old and those above 90 years old will be excluded.

Design outcomes

Primary

Measure	Time frame
We will assess the prognosis optimistically. Prognosis encompasses overall survival duration, occurrence of hepatic events, cardiovascular events, development of multi-organ cancers, and onset of renal failure.	—

Secondary

Measure	Time frame
Clinical laboratory values (WBC, RBC, Hb, Plt, PT%, TP, Alb, BUN, Cre, eGFR, Na, K, Cl, T-Bil, D-Bil, I-Bil, AST, ALT, AFP, AFP-L3, PIVKA-II, 4th generation C7S, M2BPGi, Autotaxin, anti-mitochondrial antibodies, anti-M2 mitochondrial antibodies, anti-centromere antibodies, anti-nuclear antibodies, anti-nuclear membrane antibodies, urine qualitative test, urine sediment, etc.), body composition (Inbody), liver histopathology findings, imaging findings (CT, MRI, US, Fibroscan).	—

Measure

Time frame

Clinical laboratory values (WBC, RBC, Hb, Plt, PT%, TP, Alb, BUN, Cre, eGFR, Na, K, Cl, T-Bil, D-Bil, I-Bil, AST, ALT, AFP, AFP-L3, PIVKA-II, 4th generation C7S, M2BPGi, Autotaxin, anti-mitochondrial antibodies, anti-M2 mitochondrial antibodies, anti-centromere antibodies, anti-nuclear antibodies, anti-nuclear membrane antibodies, urine qualitative test, urine sediment, etc.), body composition (Inbody), liver histopathology findings, imaging findings (CT, MRI, US, Fibroscan).

—

Countries

Japan

Contacts

Public ContactTakanobu Iwadare

Shinshu University School of Medicine Department of Medicine, Division of Gastroenterology and Hepatology

22hm104g@shinshu-u-ac.jp0263372634

Outcome results