AI Models vs Non-Invasive Fibrosis Scores in MAFLD Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

522 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-13

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MAFLD AI (Artificial Intelligence)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nahla Ahmed Khalaf

Lecturer of Tropical Medicine and Infectious diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine

Tanta, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TANTAU-MAFLD-AI-2025-01

Identifier Type: -

Identifier Source: org_study_id