An observational study in Liver Fibrosis and Beta Thalassemia Major, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Tanta University · Observational
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 100 is below the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
measuring hepcidin level (nanogram/ml) for predicting iron overload
Time frame: through study completion, an average 6 months
measuring ferritin level (nanogram/ml) for predicting significant fibrosis
Time frame: through study completion, an average 6 months
measuring hepcidin level (nanogram/ml) for predicting significant fibrosis
Time frame: through study completion, an average of 6 months
comparing serum ferritin versus non-invasive scores for significant fibrosis
Time frame: through study completion, an average of 6 months
comparing serum hepcidin versus non-invasive scores for significant fibrosis
Time frame: through study completion, an average of 6 months
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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