Metabolic Dysfunction Associated Steatotic Liver DiseaseNCT06795646
Clinical Classification of MAFLD Based Liver Biopsy
An observational study of Metabolic Dysfunction Associated Steatotic Liver Disease and Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Beijing Friendship Hospital at 6 sites in China.
Trial summary
Metabolic dysfunction-associated Fatty Liver Disease (MAFLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common chronic progressive liver disease in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Dysfunction Associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis (MASH)
- How many people
- 2,000 participants
- Where
- 6 sitesChina
- Study dates
- 8 Feb 2025to 31 Dec 2038
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MAFLD patients diagnosis by liver biopsy
Who may be able to join
- Ultrasound confirmation of fatty liver and the presence of at least one of the following metabolic cardiovascular risk factors:
- BMI ≥ 24 kg/m² or waist circumference ≥ 90 cm (men) and 85 cm (women) or excessive body fat content and body fat percentage.
- Fasting blood glucose ≥ 6.1 mmol/L or 2-hour post-load blood glucose ≥ 7.8 mmol/L or HbA1c ≥ 5.7% or history of Type 2 Diabetes Mellitus (T2DM) or Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.
- Fasting serum triglycerides ≥ 1.70 mmol/L or currently receiving lipid-lowering drug therapy.
- Serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol/L (men) and 1.3 mmol/L (women) or currently receiving lipid-lowering drug therapy.
- Blood pressure ≥ 130/85 mmHg or currently receiving antihypertensive drug therapy.
- histology of liver-biopsy
Who cannot join
- Excessive Alcohol Consumption: Individuals who consume alcohol equivalent to ≥30 grams of ethanol per day for males, or ≥20 grams of ethanol per day for females, or those with missing alcohol consumption information.
- Viral Hepatitis Markers: Individuals who are positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C virus (HCV) antibodies, or have missing information regarding these markers.
- History of Serious Medical Conditions: Individuals with a history of malignant tumors, cardiovascular diseases, chronic kidney disease, decompensated liver cirrhosis (manifested by ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc.), or those who have undergone liver transplantation.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Xicheng, 100050
Jingjie Zhao, 01063138328, zhaojj@ccmu.edu.cn
Hong You
Hangzhou Normal University Affiliated Hospital
Hangzhou, Xicheng, 100050
Chunlan Liu, +8618325321386, liuchunlan2025@163.com
Junping Shi
Zhongshan Hospital, Fudan University
Shanghai, Xicheng, 100050
Xinyu Yang, +8618800332829, yangxy1105@163.com
Hua Bian
Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Xiaolin Wang, +8613916785394, visit-12345@hotmail.com
Qing Xie
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Ruixu Yang, +8615000600658, fattyliver2004@126.com
Jiangao Fan
Tianjin Second People's Hospital
Tianjin
Huan Liu, +8613622105240, 13622105240@126.com
Liang Xu
About this study
Official title: Clinical Classification and Prediction System of MAFLD Based on Liver Biopsy
Metabolic dysfunction-associated Fatty Liver Disease (MAFLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common chronic progressive liver disease in China. It is closely related to the high incidence of cardiovascular-renal-metabolic syndrome and both liver and non-liver malignancies, posing a serious threat to public health. However, the diagnostic criteria for MAFLD are not unified globally, and the classification and staging still rely on liver biopsy for pathological assessment. The characteristics, mechanisms, and predictive indicators of liver and extrahepatic disease outcomes in MAFLD patients are not yet clear.
The severe form of MAFLD, metabolic dysfunction-associated steatohepatitis (MASH), has been a hot and challenging area of research for non-invasive tests (NITs). However, serum markers, imaging examinations, and novel markers under development cannot replace liver biopsy for the diagnosis of MASH. Clinically, the disease outcomes of MAFLD mainly depend on metabolic cardiovascular risk factors and fibrosis staging. Both liver biopsy and NIT-diagnosed advanced fibrosis and cirrhosis can predict liver-related events and all-cause mortality risks in MAFLD patients. Artificial intelligence and machine learning methods can improve the consistency of pathologists in diagnosing MASH and fibrosis. The Agile score, which combines gender, T2DM status, AST/ALT ratio, platelet count, and liver stiffness measurement (LSM), can improve the diagnostic efficacy of advanced fibrosis and cirrhosis in MAFLD patients and the efficiency of predicting liver-related events. However, the predictive effect of fibrosis staging and its changes on liver cancer needs to be improved. There is a lack of high-quality research on early warning indicators for the incidence of CVD, chronic kidney disease, and non-liver malignancies in MAFLD patients. It is necessary to explore the role of conventional indicators such as low-density lipoprotein cholesterol, lipoprotein(a), uric acid, and high-sensitivity C-reactive protein, as well as multi-omics parameters, in the classification, staging, and risk prediction of MAFLD.
MAFLD is an increasingly serious public health issue associated with a higher risk of liver-related events, cardiovascular-renal-metabolic syndrome, and malignancies. The prevalence of MAFLD in China is high, but the rate of standardized management is low. Even patients with the same classification and staging often have different clinical characteristics and outcomes. There is currently a lack of a clinical classification and early warning system for MAFLD that combines metabolic cardiovascular risk factors and NITs for different outcome risks.
Read the detailed description
- Recruitment and Data Collection: On the basis of an existing cohort of 1,500 liver biopsy cases, recruit an additional 500 cases from a national multicenter liver biopsy follow-up cohort (totaling 2,000 cases). Collect demographic, anthropometric, laboratory, imaging, and liver biopsy results for these patients. Concurrently, biological samples, including blood, urine, feces, and liver biopsy tissues, will be collected. Utilize these samples to perform quantitative metabolite information based on database matching. Employ techniques such as genomics, epigenomics, proteomics, metabolomics, immunomics, and microbiome metagenomics to screen for differential biomarkers across different subgroups. Combine these findings with clinical and imaging parameters of MAFLD patients to analyze and explore key parameters and molecules at different stages and outcomes of MAFLD disease progression.
- Development and Validation of a Diagnostic and Prognostic System:
Based on key molecules identified through multi-omics, in conjunction with characteristic parameters from clinical and imaging data of MAFLD patients, use machine learning methods (such as random forests neural networks) combined with logistic regression to establish a novel non-invasive diagnostic and prognostic assessment system for adverse outcomes (cardiovascular events, non-liver malignancies, and liver-related events).
Validate this new assessment system to ensure its reliability and accuracy in predicting disease outcomes.
- Conditions
- Metabolic Dysfunction Associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis (MASH)
- Keywords
- MAFLD, MASLD, liver-biopsy, classification, prediction model
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 |
|---|---|---|
| MAFLD diagnosed by liver-biopsy | retrospective and prospective cohort about MAFLD diagnosed by liver-biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint
Number of participants with the composite endpoint, including
- Liver-Related Events:
Cirrhosis Liver decompensation Hepatocellular carcinoma Liver transplantation
- Metabolic Diseases:
Type 2 Diabetes Mellitus (T2DM) Hypertension Dyslipidemia Gout
- Cardiovascular Diseases (CVD):
Coronary heart disease Stroke Heart failure Atrial fibrillation
- Non-Liver Malignancies:
Colorectal adenoma/adenocarcinoma Gastric cancer Esophageal cancer Pancreatic cancer Gallbladder cancer Lung cancer Prostate cancer Hematological malignancies E. Chronic Kidney Disease
- Mortality:
Liver disease-related deaths Cardiovascular disease-related deaths Other causes of death
Measured: 1-20 years
Secondary outcomes (6)
Liver-Related Events
Number of participants with liver-related events, including Cirrhosis, Liver decompensation, Hepatocellular carcinoma, Liver transplantation
Measured: 1-20 years
Metabolic Diseases
Number of participants with metabolic disease, including Type 2 Diabetes Mellitus (T2DM), Hypertension, Dyslipidemia, Gout
Measured: 1-20 years
Cardiovascular Diseases (CVD)
Number of participants with CVD, including Coronary heart disease, Stroke, Heart failure, Atrial fibrillation
Measured: 1-20 years
Non-Liver Tumors
Number of participants with non-liver tumors, including colorectal adenoma/adenocarcinoma, gastric cancer, esophageal cancer, pancreatic cancer, gallbladder cancer, lung cancer, prostate cancer, hematological malignancies and so on
Measured: 1-20 years
Chronic Kidney Disease
Number of participants with chronic kidney disease
Measured: 1-20 years
Mortality
Number of participants including liver disease-related deaths, cardiovascular disease-related deaths, and Other causes of death
Measured: 1-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start8 Feb 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Steatotic 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Tianjin Second People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Affiliated Hospital of Hangzhou Normal University, Ruijin Hospital
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, PhD. / M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795646
- Sponsor's protocol ID
- 2023ZD0508702
- Other IDs
- 2023ZD0508702
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient Demographics, Anthropometrics, Serological, and Imaging Data, and Liver Biopsy Scores
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Classification and Prediction System of MAFLD Based on Liver Biopsy
- ClinicalTrials.gov ID
- NCT06795646
- Acronym / sponsor ID
- 2023ZD0508702
- Conditions
- Metabolic Dysfunction Associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis (MASH)
- Keywords
- MAFLD, MASLD, liver-biopsy, classification, prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Fudan University, Tianjin Second People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Affiliated Hospital of Hangzhou Normal University, Ruijin Hospital
- Study start
- 8 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 28 Jan 2025 (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 dysfunction-associated Fatty Liver Disease (MAFLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common chronic progressive liver disease in China. It is closely related to the high incidence of cardiovascular-renal-metabolic syndrome and both liver and non-liver malignancies, posing a serious threat to public health. However, the diagnostic criteria for MAFLD are not unified globally, and the classification and staging still rely on liver biopsy for pathological assessment. The characteristics, mechanisms, and predictive indicators of liver and extrahepatic disease outcomes in MAFLD patients are not yet clear.
The severe form of MAFLD, metabolic dysfunction-associated steatohepatitis (MASH), has been a hot and challenging area of research for non-invasive tests (NITs). However, serum markers, imaging examinations, and novel markers under development cannot replace liver biopsy for the diagnosis of MASH. Clinically, the disease outcomes of MAFLD mainly depend on metabolic cardiovascular risk factors and fibrosis staging. Both liver biopsy and NIT-diagnosed advanced fibrosis and cirrhosis can predict liver-related events and all-cause mortality risks in MAFLD patients. Artificial intelligence and machine learning methods can improve the consistency of pathologists in diagnosing MASH and fibrosis. The Agile score, which combines gender, T2DM status, AST/ALT ratio, platelet count, and liver stiffness measurement (LSM), can improve the diagnostic efficacy of advanced fibrosis and cirrhosis in MAFLD patients and the efficiency of predicting liver-related events. However, the predictive effect of fibrosis staging and its changes on liver cancer needs to be improved. There is a lack of high-quality research on early warning indicators for the incidence of CVD, chronic kidney disease, and non-liver malignancies in MAFLD patients. It is necessary to explore the role of conventional indicators such as low-density lipoprotein cholesterol, lipoprotein(a), uric acid, and high-sensitivity C-reactive protein, as well as multi-omics parameters, in the classification, staging, and risk prediction of MAFLD.
MAFLD is an increasingly serious public health issue associated with a higher risk of liver-related events, cardiovascular-renal-metabolic syndrome, and malignancies. The prevalence of MAFLD in China is high, but the rate of standardized management is low. Even patients with the same classification and staging often have different clinical characteristics and outcomes. There is currently a lack of a clinical classification and early warning system for MAFLD that combines metabolic cardiovascular risk factors and NITs for different outcome risks.
Detailed description
- Recruitment and Data Collection: On the basis of an existing cohort of 1,500 liver biopsy cases, recruit an additional 500 cases from a national multicenter liver biopsy follow-up cohort (totaling 2,000 cases). Collect demographic, anthropometric, laboratory, imaging, and liver biopsy results for these patients. Concurrently, biological samples, including blood, urine, feces, and liver biopsy tissues, will be collected. Utilize these samples to perform quantitative metabolite information based on database matching. Employ techniques such as genomics, epigenomics, proteomics, metabolomics, immunomics, and microbiome metagenomics to screen for differential biomarkers across different subgroups. Combine these findings with clinical and imaging parameters of MAFLD patients to analyze and explore key parameters and molecules at different stages and outcomes of MAFLD disease progression.
- Development and Validation of a Diagnostic and Prognostic System:
Based on key molecules identified through multi-omics, in conjunction with characteristic parameters from clinical and imaging data of MAFLD patients, use machine learning methods (such as random forests neural networks) combined with logistic regression to establish a novel non-invasive diagnostic and prognostic assessment system for adverse outcomes (cardiovascular events, non-liver malignancies, and liver-related events).
Validate this new assessment system to ensure its reliability and accuracy in predicting disease outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAFLD diagnosed by liver-biopsy | – | –retrospective and prospective cohort about MAFLD diagnosed by liver-biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MAFLD patients diagnosis by liver biopsy
Key inclusion criteria (7 listed)
- Ultrasound confirmation of fatty liver and the presence of at least one of the following metabolic cardiovascular risk factors:
- histology of liver-biopsy
Key exclusion criteria (3 listed)
- Excessive Alcohol Consumption: Individuals who consume alcohol equivalent to ≥30 grams of ethanol per day for males, or ≥20 grams of ethanol per day for females, or those with missing alcohol consumption information.
- Viral Hepatitis Markers: Individuals who are positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C virus (HCV) antibodies, or have missing information regarding these markers.
- History of Serious Medical Conditions: Individuals with a history of malignant tumors, cardiovascular diseases, chronic kidney disease, decompensated liver cirrhosis (manifested by ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc.), or those who have undergone liver transplantation.
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
composite endpoint
Time frame: 1-20 years
Number of participants with the composite endpoint, including A. Liver-Related Events: Cirrhosis Liver decompensation Hepatocellular carcinoma Liver transplantation B. Metabolic Diseases: Type 2 Diabetes Mellitus (T2DM) Hypertension Dyslipidemia Gout C. Cardiovascular Diseases (CVD): Coronary heart disease Stroke Heart failure Atrial fibrillation D. Non-Liver Malignancies: Colorectal adenoma/adenocarcinoma Gastric cancer Esophageal cancer Pancreatic cancer Gallbladder cancer Lung cancer Prostate cancer Hematological malignancies E. Chronic Kidney Disease F. Mortality: Liver disease-related deaths Cardiovascular disease-related deaths Other causes of death
6 secondary outcomes
Liver-Related Events
Time frame: 1-20 years
Metabolic Diseases
Time frame: 1-20 years
Cardiovascular Diseases (CVD)
Time frame: 1-20 years
Non-Liver Tumors
Time frame: 1-20 years
Chronic Kidney Disease
Time frame: 1-20 years
Mortality
Time frame: 1-20 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 12 Feb 2025.
- Individual participant dataSharing planned: Yes. Patient Demographics, Anthropometrics, Serological, and Imaging Data, and Liver Biopsy Scores
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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.
Hong You, PhD. / M.D. principal investigator
Beijing Friendship Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction Associated Steatotic Liver Disease and Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Beijing Friendship Hospital at 6 sites 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 7 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Jingjie Zhao, M.D. (01063138328, zhaojj@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint (time frame: 1-20 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 12 Feb 2025.