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

NCT05653830 | Unknown

• 1 other identifier: XJTU1AF2022LSK-300
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Liver Disease

Keywords

retrospective-prospective, observational clinical study of chronic liver disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Incidence of complications related to cirrhosis

  10years

• Progression rate of liver fibrosis

  10years

Study Arms (6)

Patients with chronic hepatitis B

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

Patients with chronic hepatitis C

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

Patients with chronic hepatitis D

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

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

Patients with NAFLD

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

Patients with ALD

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Long-term follow-up of patients with chronic liver disease managed by liver disease centers and infectious disease centers in Shaanxi, Ningxia, Gansu, Qinghai, Xinjiang and other places

You may qualify if:

• Patients who regularly visit and follow up at the corresponding liver disease center
• 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

You may not qualify if:

• First visit diagnosed with hepatocellular carcinoma or after liver transplantation.
• Combined with other advanced malignant tumors.
• The patient refused to sign the informed consent form to participate in this study.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Ankang Central Hospital: collaborator
• 3201 Hospital in Hanzhong: collaborator
• Weinan Central Hospital: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Tang-Du Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Lanzhou University Second Hospital: collaborator
• First Affiliated Hospital of Lanzhou University: collaborator
• The Fourth People's Hospital of Qinghai Province: collaborator
• Yan'an University Affiliated Hospital: collaborator

Study Sites (1)

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

3 ml of serum was retained for prospective patient and stored frozen below -80 degrees

Study Officials

• Yingli He

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Xiaonan Wu

CONTACT

008615686231404; w793402903@163.com

Yingli He

CONTACT

008618991232863; heyingli2000@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 16, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 16, 2022

Record last verified: 2022-08

Locations

CN (1)