Hereditary SpherocytosisNCT07842718
New CBC Parameters in Diagnosis of Hereditary Spherocytosis
An observational study of Hereditary Spherocytosis and Hemolytic Anemia, run by Assiut University.
Trial summary
This cross-sectional study aims to evaluate the diagnostic performance of selected automated complete blood count-derived erythrocytic and reticulocytic parameters in children with hereditary spherocytosis. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Spherocytosis, Hemolytic Anemia
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 25 Mar 2028
- Phase
- Observational
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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged 1 month to 18 years evaluated for hereditary spherocytosis or included as comparison participants at Assiut University Children's Hospital.
Who may be able to join
- Age 1 month to 18 years
- Children with confirmed hereditary spherocytosis according to clinical and laboratory criteria, or age-appropriate children without evidence of hereditary spherocytosis
- Availability of CBC and reticulocyte parameters
- Written informed consent from parent or legal guardian
Who cannot join
- Recent blood transfusion likely to influence red cell indices or reticulocyte parameters
- Insufficient or unsuitable blood sample for automated analysis
- Incomplete clinical or laboratory data required for classification
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Novel CBC-Derived Erythrocytic and Reticulocytic Parameters for the Diagnosis of Hereditary Spherocytosis in Children
This cross-sectional study aims to evaluate the diagnostic performance of selected automated complete blood count-derived erythrocytic and reticulocytic parameters in children with hereditary spherocytosis.
Read the detailed description
Hereditary spherocytosis is an inherited red blood cell membrane disorder. Modern automated hematology analyzers provide additional erythrocytic and reticulocytic parameters that may aid in its recognition.
This observational study will include children with confirmed or clinically suspected hereditary spherocytosis and a comparison group without hereditary spherocytosis. Complete blood count and reticulocyte parameters including mean reticulocyte volume (MRV), immature reticulocyte fraction (IRF), Ret/IRF ratio, and MicroR will be evaluated.
- Conditions
- Hereditary Spherocytosis, Hemolytic Anemia
- Keywords
- Hereditary spherocytosis, IRF, Assiut, CBC parameters, MRV, Reticulocyte
- Medical subject headings
- Spherocytosis, Hereditary, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hereditary Spherocytosis | Children with confirmed hereditary spherocytosis. | |
| Comparison Group | Age-appropriate children without evidence of hereditary spherocytosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of mean reticulocyte volume (MRV)
Sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve of mean reticulocyte volume (MRV) for identifying hereditary spherocytosis.
Measured: Baseline
Secondary outcomes (5)
Diagnostic performance of Ret/IRF ratio
Sensitivity, specificity, and area under the ROC curve of the reticulocyte/IRF ratio for identifying hereditary spherocytosis.
Measured: Baseline
Diagnostic performance of immature reticulocyte fraction (IRF)
Sensitivity, specificity, and area under the ROC curve of immature reticulocyte fraction for identifying hereditary spherocytosis.
Measured: Baseline
Diagnostic performance of MicroR
Sensitivity, specificity, and area under the ROC curve of percentage of microcytic red cells (MicroR) for identifying hereditary spherocytosis.
Measured: Baseline
Mean hemoglobin level
Mean hemoglobin concentration in g/dL compared between hereditary spherocytosis and non-hereditary spherocytosis groups.
Measured: Baseline
Mean MCHC
Mean corpuscular hemoglobin concentration compared between groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary SpherocytosisStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariaam Samir William Zakhary, Assiut University
- Investigators
- Khaled I EL Saieh, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842718
- Sponsor's protocol ID
- HS-CBC-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No