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Simple blood tests may spot liver damage in thalassemia kids

NCT ID NCT07153926

Diagnosis Sponsor: Tanta University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at 100 children with beta-thalassemia major and iron overload to see if simple blood tests (ferritin and hepcidin) can detect liver scarring (fibrosis) as accurately as other non-invasive methods. Researchers measured these blood markers and compared them to ultrasound-based elastography and calculated scores. The goal is to find a reliable, needle-free way to monitor liver health in these children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to simpler, non-invasive blood tests to detect liver damage in children with thalassemia, reducing the need for liver biopsies.
What could go wrong
This is a small, completed observational study, not a treatment trial. The results may not apply to all children or other conditions, and the tests may not be accurate enough to replace current methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Sep 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

5 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

beta thalassemia beta-thalassemia major cirrhosis of liver fibrotic liver disease Iron Overload iron poisoning

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Beta-thalassemia major Liver fibrosis

Contacts and locations

Locations

  • Tanta University Hospitals

    Tanta, Gharbyea, 31516, Egypt

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