NCT06061640

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

September 25, 2023

Last Update Submit

September 25, 2023

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease

Outcome Measures

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.

    2022-2024

Secondary Outcomes (2)

  • Accuracy

    2022-2024

  • Precision

    2022-2024

Study Arms (2)

case group

MAFLD patients

control group

health people

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • significant drinking history (weekly alcohol consumption ≥ 140g for male, or weekly alcohol consumption ≥ 70g for female);
  • 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;
  • major organ malfunction, severe systemic illnesses, mental health issues, or inability to complete examination;
  • pregnant or pregnancy planning female;
  • missing of important clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Clinical Medical College of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310003, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

September 29, 2023

Study Start

June 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

CN(1)