Chronic Liver DiseaseNCT05653830
Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease
An observational study of Chronic Liver Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an
Yingli He, 08618991232863, heyingli2000@163.com
About this study
Official title: Multicenter, Retrospective-prospective, Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease
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.
Read the detailed 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.
- Conditions
- Chronic Liver Disease
- Keywords
- retrospective-prospective, observational clinical study of chronic liver disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10years
Secondary outcomes (2)
Incidence of complications related to cirrhosis
Incidence of various cirrhosis related complications, including infection, hepatic encephalopathy, gastrointestinal bleeding, ascites, hepatorenal syndrome, etc
Measured: 10years
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
Measured: 10years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ankang Central Hospital, 3201 Hospital in Hanzhong, Weinan Central Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Tang-Du Hospital, First Affiliated Hospital of Xinjiang Medical University, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, LanZhou University, The Fourth People's Hospital of Qinghai Province, Yan'an University Affiliated Hospital
- Responsible party
- Sponsor
- Investigators
- Yingli He, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653830
- Sponsor's protocol ID
- XJTU1AF2022LSK-300
- Status last verified
- Aug 2022
- First submitted
- 9 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Retrospective-prospective, Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05653830
- Acronym / sponsor ID
- XJTU1AF2022LSK-300
- Conditions
- Chronic Liver Disease
- Keywords
- retrospective-prospective, observational clinical study of chronic liver disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Ankang Central Hospital, 3201 Hospital in Hanzhong, Weinan Central Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Tang-Du Hospital, First Affiliated Hospital of Xinjiang Medical University, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, LanZhou University, The Fourth People's Hospital of Qinghai Province, Yan'an University Affiliated Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality (liver transplantation) rate in patients with chronic liver disease
Time frame: 10years
Clinical data from patients with chronic liver disease are recorded until the patient's death or liver transplantation
Incidence of liver cancer or decompensated cirrhosis in patients with chronic liver disease
Time frame: 10years
The incidence of progression to liver cancer or decompensated cirrhosis in patients with chronic liver disease was statistically collected
2 secondary outcomes
Incidence of complications related to cirrhosis
Time frame: 10years
Progression rate of liver fibrosis
Time frame: 10years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingli He study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaonan Wu (008615686231404, w793402903@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (liver transplantation) rate in patients with chronic liver disease (time frame: 10years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.