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Clinical Trials/NCT06492369
NCT06492369CompletedNot Applicable

The Accuracy of MAFLD Fibrosis Score in Detecting Fibrotic NASH in MAFLD Egyptian Patients

Tanta University1 site in 1 country382 target enrollmentStarted: March 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
382
Locations
1
Primary Endpoint
Accuracy of MFS in detecting Fibrotic NASH

Study Overview

Brief Summary

Metabolic-associated fatty liver disease (MAFLD), is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration.

The incidence of MAFLD is increasing yearly, and its incidence rate is as high as 20% to 30% on a global scale, which seriously affects people's health. Non-alcoholic steatohepatitis (NASH), a chronic hepatitis that can progress to advanced fibrosis, decompensated cirrhosis, and hepatocellular carcinoma, affects one-fifth of NAFLD patients. Depending on the histological severity of fibrosis, patients with NASH can be further classified as early NASH (F0-F1 fibrosis), fibrotic NASH (≥F2 fibrosis), or NASH-cirrhosis (F4 fibrosis).

Identifying subjects with fibrotic NASH is essential as they are at risk of complications, and disease progression and may benefit from potential pharmacological therapy.

Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy, but liver biopsy is invasive and limited by cost, sampling variability, and intrareader/interreader variability.

Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers, imaging, and algorithms combining both. The FibroScan-AST (FAST) composite score is based on the liver stiffness measure (LSM), controlled attenuation potential (CAP), and AST. At the cut-off of a FAST score ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score [NAS] ≥4 and fibrosis ≥2) can be ruled in with 90% specificity.

A new predictive model was recently developed based on eight variables (age, BMI, HbA1c, history of type 2 diabetes, International normalized ratio (INR), AST, Gamma Glutamyl transferase (GGT), and platelet count). A composite score MAFLD Fibrosis Score (MFS) was calculated as: MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).

So, in this study, the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score (MFS) vs AST- to-platelet ratio index (APRI) score, fibrosis-4 index (FIB-4) score, and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients.

Detailed Description

This study will be a cross-sectional study and will be carried out on 380 MAFLD patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in March 2024 to August 2024 or until collecting the cases.

Sample size The study will be carried on 382 patients according to the prevalence in Egypt 47.5% with confidence level 95% and margin of error 5 All the patients will be subjected to;

History taking:

Full history taking including:

  • Personal history (name, age, sex, occupation, residence and marital state).
  • Anthropometric measures: weight, length, BMI, Waist circumference.
  • Complaint.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female patients older than 18 years.
  • •NAFLD Patients assessed by ultrasound, fibroscan.

Exclusion Criteria

  • •Patients aged < 18 years
  • •pregnant women.
  • •Excess alcohol intake (more than 30 g in men and 20 g in women).
  • •Viral hepatitis.
  • •Autoimmune hepatitis
  • •secondary fatty liver (e.g., the use of systemic steroids or methotrexate).
  • •history of malignancy in the past 2 years.
  • •Unwilling to participate in our study.

Outcomes

Primary Outcomes

Accuracy of MFS in detecting Fibrotic NASH

Time Frame: till August 2024

evaluation of accuracy of MAFLD Fibrosis Score (MFS) in the assessment of the fibrotic NASH in Egyptian patients.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rania Mamdouh Elkafoury

Principle Investigator

Tanta University

Study Sites (1)

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