BeijngFH Health Cohort Study

Non-Alcoholic Fatty Liver Disease Clinical Trial

— FHCS  

Official title:

Risk Prediction System for Metabolic Associated Fatty Liver Disease, a Community-based Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546086
• Other study ID #: CFH2022-1-2021
• Status: Recruiting
• Start date: April 18, 2022
• Est. completion date: April 18, 2032

Study information

• Verified date: September 2022
• Source: Beijing Friendship Hospital
• Contact: Hong You, Doctor
• Phone: 86-010-63139019
• Email: youhong30[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Metabolic associated fatty liver disease(MEFLD) is a major chronic liver disease that can lead to various adverse events, such as liver cancer, cardiovascular disease, and chronic kidney disease. The present community-based cohort study enrolls subjects who take health physical examinations at the sub-center outpatient department, Beijing Friendship Hospital. Investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, imageological examination, and so on. Follow-up surveys are conducted annually and the information collected is the same as the baseline. The outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, are obtained by linking to the hospital discharge database and death registration system of Beijing. The primary aim of the study is to build a risk-stratified evaluation system for MAFLD through the cohort.

Description:

The present community-based cohort study enrolls subjects who take physical health examinations at the sub-center outpatient department, Beijing Friendship Hospital. After signing the informed consent, Their previous health physical examination results, which were recorded in the Hospital Information System (HIS) are collected retrospectively. Then, Investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, image logical examination, and so on. Additionally, follow-up surveys will be conducted annually and the information collected is the same as the baseline. The outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, is obtained from the hospital discharge database and death registration system in Beijing. The study's primary aim is to build a risk-stratified evaluation system for MAFLD through a community population cohort with long-term stable follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8103
• Est. completion date: April 18, 2032
• Est. primary completion date: April 18, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older
• Permanent residents in Beijing
• Signing informed consent

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease	Incidence of cardiovascular disease during follow-ups	1 to 10 years
Secondary	Malignancy	Incidence of malignancy during follow-ups	1 to 10 years
Secondary	Liver cirrhosis	Incidence of liver cirrhosis during follow-ups	1 to 10 years
Secondary	Liver decompensation	Incidence of liver decompensation during follow-ups	1 to 10 years
Secondary	Liver transplantation	Incidence of liver transplantation during follow-ups	1 to 10 years
Secondary	All-cause mortality	Incidence of all-cause mortality during follow-ups	1 to 10 years