CClinicalTrials.gg
Active, not recruitingNCT06061640Updated Sep 29, 2023

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

An observational study in Metabolic Dysfunction-associated Fatty Liver Disease, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Metabolic Dysfunction-associated Fatty Liver Disease
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 500 is above the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University is the lead sponsor of 37 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • case group

    MAFLD patients

  • control group

    health people

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2022-2024

Secondary outcomes

  1. Accuracy

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

    Time frame: 2022-2024

  2. Precision

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

    Time frame: 2022-2024

07

Study locations

1 site
  • The First Clinical Medical College of Zhejiang Chinese Medical University
    Hangzhou, Zhejiang 310003, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06061640
Lead sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborators
Zhejiang Chinese Medical University
Responsible party
Sponsor
First posted
Sep 29, 2023
Start date
Jun 1, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 29, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion