Vibration Controlled Tissue Elastography Versus Iron Regulators as Diagnostic Tools for Hepatic Fibrosis - Iron Overload in Egyptian Children With Beta- Thalassemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- measuring hepcidin level (nanogram/ml) for predicting iron overload
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with ß-thalassemia major
- •iron overload, as indicated by serum ferritin levels more than 500 ng/mL.
排除标准
- •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.
结局指标
主要结局
measuring hepcidin level (nanogram/ml) for predicting iron overload
时间窗: through study completion, an average 6 months
measuring ferritin level (nanogram/ml) for predicting significant fibrosis
时间窗: through study completion, an average 6 months
measuring hepcidin level (nanogram/ml) for predicting significant fibrosis
时间窗: through study completion, an average of 6 months
次要结局
- 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)
研究者
Rania Mamdouh Elkafoury
Lecturer of Tropical medicine
Tanta University