Liver FibrosisNCT07153926
Elastography vs Iron Regulators in the Diagnosis of Hepatic Fibrosis- Iron Overload in Children With Beta- Thalassemia
An observational study of Liver Fibrosis and Beta Thalassemia Major, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Liver Fibrosis, Beta Thalassemia Major
- What is being tested?
- Serum ferritin and Serum hepcidin
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2024to 2 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Children with ß-thalassemia major
- iron overload, as indicated by serum ferritin levels more than 500 ng/mL.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vibration Controlled Tissue Elastography Versus Iron Regulators as Diagnostic Tools for Hepatic Fibrosis - Iron Overload in Egyptian 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.
- Conditions
- Liver Fibrosis, Beta Thalassemia Major
- Being tested
- Serum ferritin, Serum hepcidin
- Keywords
- Fibroscan, Liver fibrosis, Iron overload, Beta- thalassemia
- Medical subject headings
- Liver Cirrhosis, beta-Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum ferritinDiagnostic 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 hepcidinDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serum ferritin; Diagnostic Test: Serum hepcidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring hepcidin level (nanogram/ml) for predicting iron overload
Measured: through study completion, an average 6 months
measuring ferritin level (nanogram/ml) for predicting significant fibrosis
Measured: through study completion, an average 6 months
measuring hepcidin level (nanogram/ml) for predicting significant fibrosis
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
comparing serum ferritin versus non-invasive scores for significant fibrosis
Measured: through study completion, an average of 6 months
comparing serum hepcidin versus non-invasive scores for significant fibrosis
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start12 Sep 2024
- Primary completion15 Mar 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153926
- Sponsor's protocol ID
- 36264PR872/9/24
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Controlled Tissue Elastography Versus Iron Regulators as Diagnostic Tools for Hepatic Fibrosis - Iron Overload in Egyptian Children With Beta- Thalassemia
- ClinicalTrials.gov ID
- NCT07153926
- Acronym / sponsor ID
- 36264PR872/9/24
- Conditions
- Liver Fibrosis, Beta Thalassemia Major
- Keywords
- Fibroscan, Liver fibrosis, Iron overload, Beta- thalassemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beta- thalassemia patients | – | Diagnostic Test: Serum ferritin, Diagnostic Test: Serum hepcidin100 beta-thalassemia major children with iron overload aged 5 to 18 years, as indicated by serum ferritin levels more than 500 ng/mL. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Children with ß-thalassemia major
- iron overload, as indicated by serum ferritin levels more than 500 ng/mL.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum ferritinSerum 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. | Diagnostic test | beta- thalassemia patients |
| Serum hepcidinHepcidin 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. | Diagnostic test | beta- thalassemia patients |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Related trials for Liver Fibrosis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Beta Thalassemia Major, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring hepcidin level (nanogram/ml) for predicting iron overload (time frame: through study completion, an average 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.