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NCT07153926Completed

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

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

Source: ClinicalTrials.gov · Last updated 4 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
100 (actual)
First submitted
26 Aug 2025
Start date
12 Sept 2024
Primary completion date
15 Mar 2025
Lead sponsor
Tanta University
Diseases
Thalassaemia
NCT number
NCT07153926

What you commit to

  • Study type: Observational
  • Participants enrolled: 100
  • From 12 Sept 2024 to the primary completion date, 15 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • children with other types of chronic hemolytic anemia.

Who the study is looking for

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

Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tanta University Hospitals
Coordinator of this site? Confirm its status
TantaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.