ClinicalTrials.gg
Not yet recruitingNCT07842718Updated Oct 16, 2026

New CBC Parameters in Diagnosis of Hereditary Spherocytosis

An observational study in Hereditary Spherocytosis and Hemolytic Anemia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Assiut University · Observational

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
41
Ages
1 Month to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hereditary Spherocytosis
  • Hemolytic Anemia

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Keywords

  • Hereditary spherocytosis
  • IRF
  • Assiut
  • CBC parameters
  • MRV
  • Reticulocyte
03

In context

Anemia, Hemolytic

56 studies on the registry are indexed under Anemia, Hemolytic; 16 are open to participants now.

This study's planned enrollment of 41 is below the median of 56 across 16 observational studies indexed under Anemia, Hemolytic.

Browse Anemia, Hemolytic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 from parent or legal guardian

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
41 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hereditary Spherocytosis

    Children with confirmed hereditary spherocytosis.

  • Comparison Group

    Age-appropriate children without evidence of hereditary spherocytosis.

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. Diagnostic performance of Ret/IRF ratio

    Sensitivity, specificity, and area under the ROC curve of the reticulocyte/IRF ratio for identifying hereditary spherocytosis.

    Time frame: Baseline

  2. Diagnostic performance of immature reticulocyte fraction (IRF)

    Sensitivity, specificity, and area under the ROC curve of immature reticulocyte fraction for identifying hereditary spherocytosis.

    Time frame: Baseline

  3. Diagnostic performance of MicroR

    Sensitivity, specificity, and area under the ROC curve of percentage of microcytic red cells (MicroR) for identifying hereditary spherocytosis.

    Time frame: Baseline

  4. Mean hemoglobin level

    Mean hemoglobin concentration in g/dL compared between hereditary spherocytosis and non-hereditary spherocytosis groups.

    Time frame: Baseline

  5. Mean MCHC

    Mean corpuscular hemoglobin concentration compared between groups.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 2 updates
  1. Oct 16, 2026
    Minor edits only
    + 2 other changes: identifiers and verification date
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07842718
Lead sponsor
Assiut University
Responsible party
Mariaam Samir William Zakhary (Resident Physician, Department of Pediatrics, Assiut University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Mar 25, 2028 (estimated)
Last update
Oct 16, 2026

Study contacts

Mariaam S William, Resident
Contact
Mariam.18313400@med.aun.edu.eg
+20 10 24556619
Khaled I EL Saieh, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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