AI Models vs Non-Invasive Fibrosis Scores in MAFLD Diagnosis | NCT07305636

Studies
AI Models vs Non-Invasive Fibrosis Scores in MAFLD Diagnosis

NCT07305636

Sponsor

Tanta University

Status

Completed

Last Update Posted

Dec 26, 2025Actual

Enrollment

522Actual

Phase

Not provided

Conditions

MAFLD
AI (Artificial Intelligence)

Interventions

Not provided

Countries

Egypt

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2025Actual

Primary Completion Date

Aug 30, 2025Actual

Completion Date

Nov 30, 2025Actual

First Submitted Date

Dec 12, 2025

First Submission Date that Met QC Criteria

Dec 12, 2025

First Posted Date

Dec 26, 2025Actual

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

Dec 12, 2025

Last Update Posted Date

Dec 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 study evaluates the accuracy of artificial intelligence (AI) models using FibroScan and clinical data to predict hepatic fibrosis in Egyptian patients with metabolic-associated fatty liver disease (MAFLD). The performance of the AI models will be compared with conventional noninvasive fibrosis scores (FIB-4, APRI, NAFLD fibrosis score, and FAST). The goal is to improve early, noninvasive diagnosis of fibrosis and reduce reliance on liver biopsy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

522Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure diagnostic accuracy of AI models in predicting hepatic fibrosis stage (F0-F4)		At enrollment (single cross-sectional assessment).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Adults ≥18 years.

Diagnosed with MAFLD according to international criteria (hepatic steatosis with metabolic dysfunction).

Valid FibroScan evaluation with available LSM and CAP values.

Exclusion Criteria:

Excessive alcohol intake (>30 g/day for men, >20 g/day for women).

Chronic viral hepatitis (HBV or HCV).

Autoimmune hepatitis.

Known malignancy.

Pregnancy.

Refusal to participate.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adult Egyptian patients (≥18 years) diagnosed with metabolic associated fatty liver disease (MAFLD) according to international criteria, recruited from the outpatient clinic and FibroScan unit of the Tropical Medicine Department, Faculty of Medicine, Tanta University.

Sampling Method

Non-Probability Sample