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

NCT07153926 | Completed

• 1 other identifier: 36264PR872/9/24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Fibrosis; Beta Thalassemia Major

Keywords

Fibroscan; Liver fibrosis; Iron overload; Beta- thalassemia

Outcome Measures

Primary Outcomes (3)

• measuring hepcidin level (nanogram/ml) for predicting iron overload

  through study completion, an average 6 months

• measuring ferritin level (nanogram/ml) for predicting significant fibrosis

  through study completion, an average 6 months

• measuring hepcidin level (nanogram/ml) for predicting significant fibrosis

  through study completion, an average of 6 months

Secondary Outcomes (2)

• comparing serum ferritin versus non-invasive scores for significant fibrosis

  through study completion, an average of 6 months

• comparing serum hepcidin versus non-invasive scores for significant fibrosis

  through study completion, an average of 6 months

Study Arms (1)

beta- thalassemia patients

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

Diagnostic Test: Serum ferritin; Diagnostic Test: Serum hepcidin

Interventions

Serum ferritin DIAGNOSTIC_TEST

Serum ferritin is a protein that stores iron, and high serum ferritin levels can suggest iron overload, but are also a common indicator of other conditions like inflammation, liver disease, or metabolic syndrome.

beta- thalassemia patients

Serum hepcidin DIAGNOSTIC_TEST

Hepcidin hormone has been found to be a key regulator of iron homeostasis. It controls plasma iron levels by regulating two key steps in iron metabolism, namely digestive iron absorption in enterocytes and iron recycling in macrophages. Hepcidin is synthesized predominantly in the hepatocytes, which is physiologically increased by elevated serum iron level and decreased by erythropoietic activity. Recently, hepcidin has been used as a new marker for evaluation of liver fibrosis in patients with thalassemia major.

beta- thalassemia patients

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This cross-sectional observational study will be carried out on 100 children and adolescents who are pre-diagnosed patients with ß thalassemia major and iron overload. Patients will be enrolled from the Pediatric Gastroenterology, Hepatology \& Endoscopy and Hematology Units, Tanta University Hospital, Egypt. Fibroscan will be done in the Tropical Medicine and Infectious Diseases Department, Tanta University Hospital, Egypt. The start of research will begin in September 2024 and will end in December 2024.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis; beta-Thalassemia; Iron Overload

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical medicine

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 12, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 2, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

EG (1)