The Potential Value and Impact of Diagnostic Biomarkers for MAFLD Using Machine Learning Methods

This is a case-control study that aims to build a predictive model for MAFLD based on machine learning.

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Dysfunction-associated Fatty Liver Disease

Detailed Description

Metabolic dysfunction-associated fatty liver disease (MAFLD) also known as non-alcoholic fatty liver disease (NAFLD), is one of the most prevalent liver diseases worldwide with high prevalence and economic burden, which affects 25% of global adult population. Despite extensive research on understanding the inner pathophysiology of MAFLD, it still keep growing with no approval therapy. Therefore, preventive measures are particularly important in diagnosing MAFLD. So far the liver biopsy is still the gold standard for diagnosis of MAFLD, however considering the invasive process and potential risks, it still has low acceptance for asymptomatic patients, thus non-invasive methods are necessary for this reason.

The purpose of this study is to establish a prediction model to identify MAFLD patients, which can accurately predict whether the participants have MAFLD according to the relevant metabolic indicators of the participants, without the need for invasive examinations such as tissue biopsy.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Clinical Medical College of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Chinese participants age 18 years or older diagnosed with MAFLD on imaging and healthy volunteers without MAFLD.

Description

Inclusion Criteria:

1. aged 18 to 75 years;
2. meeting the diagnostic criteria of MAFLD;
3. no other organic lesions were found in imaging examination;
4. willing and able to sign informed consent.

Exclusion Criteria:

1. significant drinking history (weekly alcohol consumption ≥ 140g for male, or weekly alcohol consumption ≥ 70g for female);
2. presence of evidence for having hepatic steatosis, viral hepatitis, history of hepatic cancer, drug-induced liver injury, liver cirrhosis and other liver and biliary tract diseases;
3. major organ malfunction, severe systemic illnesses, mental health issues, or inability to complete examination;
4. pregnant or pregnancy planning female;
5. missing of important clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
case group; MAFLD patients
control group; health people

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under cure	Area under cure(AUC) was defined as the area enclosed by the coordinate axis under the receiver operating characteristic curve, with values ranging from 0.5 to 1.0. The closer the AUC is to 1.0, the higher the authenticity of the detection method; the closer to 0.5, the lower the authenticity of the detection method; when equal to 0.5, the authenticity is the lowest and has no application value.	2022-2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	The proportion of the number of correctly classified samples to the total number of samples.	2022-2024
Precision	The proportion of data that is actually positive among the data that is determined to be positive.	2022-2024

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Collaborators: Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: 2021-KL-202-01

Drug and device information, study documents

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