Non-Alcoholic Fatty Liver DiseaseFHCSNCT05546086
BeijngFH Health Cohort Study
An observational study of Non-Alcoholic Fatty Liver Disease, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- How many people
- 8,103 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2022to 18 Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18 years or older
- Permanent residents in Beijing
- Signing informed consent
Who cannot join
- No
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Hong You, Doctor, 13521130181, youhong30@sina.com
Xinyu Zhao, Doctor, 18612639803, zhaoxinyujuly@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Non-Alcoholic Fatty Liver Disease, Cohort Studies, Risk Factors
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease
Incidence of cardiovascular disease during follow-ups
Measured: 1 to 10 years
Secondary outcomes (5)
Malignancy
Incidence of malignancy during follow-ups
Measured: 1 to 10 years
Liver cirrhosis
Incidence of liver cirrhosis during follow-ups
Measured: 1 to 10 years
Liver decompensation
Incidence of liver decompensation during follow-ups
Measured: 1 to 10 years
Liver transplantation
Incidence of liver transplantation during follow-ups
Measured: 1 to 10 years
All-cause mortality
Incidence of all-cause mortality during follow-ups
Measured: 1 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start18 Apr 2022
- Primary completion18 Apr 2032 (estimated)
- Study completion18 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 8,103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546086
- Sponsor's protocol ID
- CFH2022-1-2021
- Acronym
- FHCS
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction System for Metabolic Associated Fatty Liver Disease, a Community-based Cohort Study
- ClinicalTrials.gov ID
- NCT05546086
- Acronym / sponsor ID
- FHCS / CFH2022-1-2021
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Non-Alcoholic Fatty Liver Disease, Cohort Studies, Risk Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,103 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 18 Apr 2032 (estimated)
- Study completion
- 18 Apr 2032 (estimated)
- First posted
- 19 Sep 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Permanent residents in Beijing
- Signing informed consent
Key exclusion criteria (1 listed)
- No
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
Cardiovascular disease
Time frame: 1 to 10 years
Incidence of cardiovascular disease during follow-ups
5 secondary outcomes
Malignancy
Time frame: 1 to 10 years
Liver cirrhosis
Time frame: 1 to 10 years
Liver decompensation
Time frame: 1 to 10 years
Liver transplantation
Time frame: 1 to 10 years
All-cause mortality
Time frame: 1 to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
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 Non-Alcoholic Fatty Liver Disease, run by Beijing Friendship Hospital 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong You, Doctor (86-010-63139019, youhong30@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease (time frame: 1 to 10 years). 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 21 Sep 2022.