BeijngFH Health Cohort Study (FHCS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 8103

Contacts and Locations

• Study Contact: Name: Xinyu Zhao, Doctor; Phone Number: 86-010-63139364; Email: zhaoxinyujuly@126.com

Study Locations

• China
  • Beijing, China, 100050
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
    • Contact: Hong You, Doctor; Phone Number: 13521130181; Email: youhong30@sina.com
    • Contact: Xinyu Zhao, Doctor; Phone Number: 18612639803; Email: zhaoxinyujuly@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The present community-based cohort study enrolls subjects who take health physical examinations at the sub-center outpatient department, Beijing Friendship Hospital from April 2022.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular disease	Incidence of cardiovascular disease during follow-ups	1 to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malignancy	Incidence of malignancy during follow-ups	1 to 10 years
Liver cirrhosis	Incidence of liver cirrhosis during follow-ups	1 to 10 years
Liver decompensation	Incidence of liver decompensation during follow-ups	1 to 10 years
Liver transplantation	Incidence of liver transplantation during follow-ups	1 to 10 years
All-cause mortality	Incidence of all-cause mortality during follow-ups	1 to 10 years

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2022
• Primary Completion (ANTICIPATED): April 18, 2032
• Study Completion (ANTICIPATED): April 18, 2032

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (ACTUAL): September 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Risk Factors; Cohort Studies; Non-Alcoholic Fatty Liver Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CFH2022-1-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No