Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease

NCT ID: NCT05653830

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Liver Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

retrospective-prospective, observational clinical study of chronic liver disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with chronic hepatitis B

Patients who meet the diagnostic criteria for chronic hepatitis B for long-term follow-up

No interventions assigned to this group

Patients with chronic hepatitis C

Patients who meet the diagnostic criteria for chronic hepatitis C for long-term follow-up

No interventions assigned to this group

Patients with chronic hepatitis D

Patients who meet the diagnostic criteria for chronic hepatitis D for long-term follow-up

No interventions assigned to this group

Patients with autoimmune liver disease(PBC\AIH\PSC)

Patients who meet the diagnostic criteria for autoimmune liver disease(PBC\\AIH\\PSC) for long-term follow-up

No interventions assigned to this group

Patients with NAFLD

Patients who meet the diagnostic criteria for NAFLD for long-term follow-up

No interventions assigned to this group

Patients with ALD

Patients who meet the diagnostic criteria for ALD for long-term follow-up

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 ③. Chronic viral hepatitis D ④. Autoimmune liver disease (PBC/AIH/PSC) ⑤. Non-alcoholic fatty liver disease ⑥. 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankang Central Hospital

OTHER

Sponsor Role collaborator

3201 Hospital in Hanzhong

OTHER

Sponsor Role collaborator

Weinan Central Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Lanzhou University

UNKNOWN

Sponsor Role collaborator

The Fourth People's Hospital of Qinghai Province

OTHER

Sponsor Role collaborator

Yan'an University Affiliated Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yingli He

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaonan Wu

Role: CONTACT

Phone: 008615686231404

Email: [email protected]

Yingli He

Role: CONTACT

Phone: 008618991232863

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yingli He

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJTU1AF2022LSK-300

Identifier Type: -

Identifier Source: org_study_id