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NCT Number: NCT07153926

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

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.

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Key information

Conditions

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

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: through study completion, an average 6 months

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

    Time frame: through study completion, an average 6 months

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

    Time frame: through study completion, an average of 6 months

Secondary outcomes

  1. comparing serum ferritin versus non-invasive scores for significant fibrosis

    Time frame: through study completion, an average of 6 months

  2. comparing serum hepcidin versus non-invasive scores for significant fibrosis

    Time frame: through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Vibration Controlled Tissue Elastography Versus Iron Regulators as Diagnostic Tools for Hepatic Fibrosis - Iron Overload in Egyptian Children With Beta- Thalassemia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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