Elastography vs Iron Regulators in the Diagnosis of Hepatic Fibrosis- Iron Overload in Children With Beta- Thalassemia

Tanta University

Status: Completed

Conditions: Beta Thalassemia Major; Liver Fibrosis

Treatments: Diagnostic Test: Serum ferritin; Diagnostic Test: Serum hepcidin

Study type: Observational

Funder types: Other

Identifiers

NCT07153926

36264PR872/9/24

Details and patient eligibility

About

The goal of this cross-sectional observational study is to evaluate the accuracy of serum ferritin and serum hepcidin versus non-invasive scores in the diagnosis of liver fibrosis and iron overload in beta- thalassemia children.

Researchers will measure and correlate serum ferritin, hepcidin and hepcidin/ferritin ratio in beta- thalassemia children with liver fibrosis. Researchers will also evaluate the performance of serum ferritin, hepcidin and hepcidin/ferritin ratio, AST to platelet ratio index (APRI) score, and fibrosis-4 (FIB-4) score, for predicting significant fibrosis (>=F2).

Participants will undergo history-taking, clinical examination, laboratory investigations, serum ferritin, serum hepcidin, abdominal ultrasonography, and Fibroscan examination. The APRI, FIB-4, and hepcidin/ferritin ratio will be calculated. The performance of serum ferritin, hepcidin and hepcidin/ferritin ratio for predicting significant fibrosis will be compared versus other non-invasive scores.

Enrollment: 100 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with ß-thalassemia major
• iron overload, as indicated by serum ferritin levels more than 500 ng/mL.

Exclusion criteria

• Pediatric patients with liver diseases (such as hepatitis).
• children with other types of chronic hemolytic anemia.
• other chronic systemic diseases (DM and Hypertension) or malignancy or heart diseases.

Trial design

100 participants in 1 patient group

beta- thalassemia patients

Description:

100 beta-thalassemia major children with iron overload aged 5 to 18 years, as indicated by serum ferritin levels more than 500 ng/mL.

Treatment:

Diagnostic Test: Serum hepcidin

Diagnostic Test: Serum ferritin