The Potential Value and Impact of Diagnostic Biomarkers f... | NCT06061640

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

NCT06061640

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status

Unknown status

Last Update Posted

Sep 29, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 25, 2023

First Submission Date that Met QC Criteria

Sep 25, 2023

First Posted Date

Sep 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2023

Last Update Posted Date

Sep 29, 2023Actual

Name	Class
Zhejiang Chinese Medical University	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case group		MAFLD patients
control group		health people

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Clinical Medical College of Zhejiang Chinese Medical University		Hangzhou	Zhejiang	310003	China