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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653830
Other study ID # XJTU1AF2022LSK-300
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2025

Study information

Verified date August 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Xiaonan Wu
Phone 008615686231404
Email w793402903@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chronic liver disease is a global public health problem. Without timely diagnosis and treatment, chronic liver disease can progress to hepatitis, liver fibrosis, and cirrhosis, while causing a variety of complications such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, and liver cancer. Early detection and treatment can slow down the progression of chronic liver disease and reduce the burden of patients. This study intends to construct a retrospective-prospective cohort of patients with chronic liver disease by building a multicenter collaborative network to study the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of chronic liver disease of different etiologies.


Description:

Different etiologies can lead to chronic liver disease, and common causes include non-alcoholic fatty liver disease (NAFLD), hepatitis B virus (HBV), hepatitis C virus (HCV), alcohol-related liver disease (ALD), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC) and autoimmune hepatitis (AIH). In recent years, with the popularization of HBV vaccination and the advancement of drugs for the treatment of viral hepatitis, the incidence of cirrhosis has been curbed in many countries, but obesity, metabolic syndrome and alcohol abuse have led to an increase in the incidence of NAFLD and ALD recently. The large number of patients with cirrhosis causes loss of social workforce and depletion of medical resources, as well as increased family stress and reduced quality of life. As a result of that, cirrhosis remains a public health problem that cannot be ignored. To better understand the natural course and clinical characteristics of chronic liver disease due to different etiologies, this study proposes to establish a multicenter, large sample, long-term follow-up cohort of patients with chronic liver disease to improve the clinical data related to chronic liver disease in China. This cohort study will help us to better manage patients with chronic liver disease and build on this foundation for epidemiology, interventions, and prognosis of chronic liver disease. The cohort and experience generated from this study serves as a support for a series of future studies to focus on clinical issues such as low-level viremia, other complications of cirrhosis, liver failure, end-stage liver disease, and liver cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 50000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients who regularly visit and follow up at the corresponding liver disease center 2. All patients meet at least one of the following diagnostic criteria for chronic liver disease: - Chronic viral hepatitis B - Chronic viral hepatitis C ?. Chronic viral hepatitis D ?. Autoimmune liver disease (PBC/AIH/PSC) ?. Non-alcoholic fatty liver disease ?. Alcoholic liver disease Exclusion Criteria: 1. First visit diagnosed with hepatocellular carcinoma or after liver transplantation. 2. Combined with other advanced malignant tumors. 3. The patient refused to sign the informed consent form to participate in this study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China First Affiliated Hospital Xi'an Jiaotong University Xi'an

Sponsors (12)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University 3201 Hospital in Hanzhong, Ankang Central Hospital, First Affiliated Hospital of Lanzhou University, First Affiliated Hospital of Xinjiang Medical University, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Lanzhou University, Second Affiliated Hospital of Xi'an Jiaotong University, Tang-Du Hospital, The Fourth People's Hospital of Qinghai Province, Weinan Central Hospital, Yan'an University Affiliated Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality (liver transplantation) rate in patients with chronic liver disease Clinical data from patients with chronic liver disease are recorded until the patient's death or liver transplantation 10years
Primary Incidence of liver cancer or decompensated cirrhosis in patients with chronic liver disease The incidence of progression to liver cancer or decompensated cirrhosis in patients with chronic liver disease was statistically collected 10years
Secondary Incidence of complications related to cirrhosis Incidence of various cirrhosis related complications, including infection, hepatic encephalopathy, gastrointestinal bleeding, ascites, hepatorenal syndrome, etc 10years
Secondary Progression rate of liver fibrosis The rate of liver fibrosis progression was assessed by liver tissue biopsy results, fibro scan results, FIB-4 score, APRI score, etc 10years
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