New CBC Parameters in Diagnosis of Hereditary Spherocytosis

NCT07842718 | Not Yet Recruiting

• 1 other identifier: HS-CBC-Assiut-2026
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hereditary Spherocytosis; Hemolytic Anemia

Keywords

Hereditary spherocytosis; IRF; Assiut; CBC parameters; MRV; Reticulocyte

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (5)

• Diagnostic performance of Ret/IRF ratio

  Baseline

• Diagnostic performance of immature reticulocyte fraction (IRF)

  Baseline

• Diagnostic performance of MicroR

  Baseline

• Mean hemoglobin level

  Baseline

• Mean MCHC

  Baseline

Study Arms (2)

Hereditary Spherocytosis

Children with confirmed hereditary spherocytosis.

Comparison Group

Age-appropriate children without evidence of hereditary spherocytosis.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 month to 18 years evaluated for hereditary spherocytosis or included as comparison participants at Assiut University Children's Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Spherocytosis, Hereditary; Anemia, Hemolytic

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Khaled I EL Saieh, prof

  Pediatrics Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Mariaam S William, Resident

CONTACT

+20 10 24556619; Mariam.18313400@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Pediatrics

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: September 26, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): March 25, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share