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

Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06061640
Collaborator
Zhejiang Chinese Medical University (Other)
500
1
19
26.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Potential Value and Impact of Diagnostic Biomarkers for MAFLD Using Machine Learning Methods
    Actual Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    case group

    MAFLD patients

    control group

    health people

    Outcome Measures

    Primary Outcome Measures

    1. Area under cure [2022-2024]

      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.

    Secondary Outcome Measures

    1. Accuracy [2022-2024]

      The proportion of the number of correctly classified samples to the total number of samples.

    2. Precision [2022-2024]

      The proportion of data that is actually positive among the data that is determined to be positive.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Clinical Medical College of Zhejiang Chinese Medical University Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • The First Affiliated Hospital of Zhejiang Chinese Medical University
    • Zhejiang Chinese Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of Zhejiang Chinese Medical University
    ClinicalTrials.gov Identifier:
    NCT06061640
    Other Study ID Numbers:
    • 2021-KL-202-01
    First Posted:
    Sep 29, 2023
    Last Update Posted:
    Sep 29, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 29, 2023