ClinicalTrials.gg
Not yet recruitingNCT07807540Updated Oct 29, 2026

Hematological Profile in Children With Numerical Chromosomal Disorders

An observational study in Down Syndrome, Turner Syndrome and Klinefelter Syndrome, sponsored by Assiut University. Not yet recruiting. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Assiut University · Observational

Updated Oct 29, 2026Start date movedPrimary completion movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
158
Ages
28 Days to 18 Years
Sex
All
01

Study summary

This cross-sectional study aims to evaluate the hematological profile and determine the frequency and pattern of hematological abnormalities in children with numerical chromosomal disorders attending the Pediatric Department of Assiut University Children's Hospital.

Read the detailed description

Numerical chromosomal disorders such as Down syndrome, Turner syndrome, Klinefelter syndrome, Edwards syndrome, and Patau syndrome are associated with various hematological abnormalities. These may include anemia, macrocytosis, thrombocytopenia, leukocyte abnormalities, and increased risk of hematological malignancies, particularly in Down syndrome.

This cross-sectional study will include children aged 28 days to 18 years with confirmed numerical chromosomal disorders. Complete blood count and peripheral blood smear examination will be performed to evaluate the hematological profile and determine the frequency and pattern of abnormalities.

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Conditions studied

  • Down Syndrome
  • Turner Syndrome
  • Klinefelter Syndrome
  • Trisomy 18
  • Chromosome Disorders

Keywords

  • Numerical chromosomal disorders
  • Hematological profile
  • Down syndrome
  • Complete blood count
  • Children
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In context

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's planned enrollment of 158 is close to the median of 158 across 145 observational studies indexed under Down Syndrome.

Browse Down Syndrome 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.

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Who can participate

Ages eligible
28 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children aged 28 days to 18 years diagnosed with numerical chromosomal disorders attending the Pediatric Department of 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 from 28 days to 18 years
  • Confirmed numerical chromosomal disorder (Down syndrome, Turner syndrome, Klinefelter syndrome, Edwards syndrome, or Patau syndrome) by karyotype
  • Written from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • - Age below 28 days
  • Patients receiving chemotherapy
  • Refusal of parents or legal guardians to participate
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.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
158 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Single cohort: Children with numerical chromosomal disorders

    Children aged 28 days to 18 years with confirmed numerical chromosomal disorders who will undergo complete blood count and peripheral blood smear examination to evaluate their hematological profile.

06

What researchers measure

Primary outcomes

  1. Frequency of hematological abnormalities

    Proportion of children with numerical chromosomal disorders who have one or more hematological abnormalities (anemia, macrocytosis, thrombocytopenia, leukopenia, leukocytosis, or abnormal peripheral blood smear findings), expressed as percentage.

    Time frame: Baseline

Secondary outcomes

  1. Pattern of hematological abnormalities

    Distribution and pattern of specific hematological abnormalities (anemia, macrocytosis, thrombocytopenia, neutropenia, etc.) among the studied children.

    Time frame: Baseline

  2. Hematological profile according to syndrome type

    Comparison of hematological parameters (hemoglobin, MCV, platelet count, white blood cell count) among different numerical chromosomal disorders (Down syndrome, Turner syndrome, and others).

    Time frame: Baseline

  3. Correlation of hematological abnormalities with clinical features

    Correlation coefficient between the presence of hematological abnormalities and clinical features (recurrent infections, bleeding manifestations, hepatosplenomegaly), using Spearman or Pearson correlation as appropriate.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Costa FF, Foly LS, Coutinho MP. DataGenno: building a new tool to bridge molecular and clinical genetics. Appl Clin Genet. 2011 Mar 18;4:45-54. doi: 10.2147/TACG.S17597. Print 2011. PubMed 23776366 ↗
  • Bull MJ. Down Syndrome. N Engl J Med. 2020 Jun 11;382(24):2344-2352. doi: 10.1056/NEJMra1706537. No abstract available. PubMed 32521135 ↗
  • Nothen MM, Propping P. Identifying genetic factors in common diseases: more helpful in relation to etiology than prediction. Dtsch Arztebl Int. 2013 May;110(19):329-30. doi: 10.3238/arztebl.2013.0329. No abstract available. PubMed 23762203 ↗
  • Gershwin LJ, Netherwood KA, Norris MS, Behrens NE, Shao MX. Equine IgE responses to non-viral vaccine components. Vaccine. 2012 Dec 14;30(52):7615-20. doi: 10.1016/j.vaccine.2012.10.029. Epub 2012 Oct 23. PubMed 23088888 ↗
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Updates

1 registry update since Sep 25, 2026
Start date
Sep 2, 2026→Nov 2, 2026
Oct 29, 2026
Primary completion
Sep 26, 2027→Nov 26, 2027
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Start date Sep 2, 2026→Nov 2, 2026
    Primary completion Sep 26, 2027→Nov 26, 2027
    + 1 other change: verification date

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 ↗

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Registry details

Key details

Study ID
NCT07807540
Lead sponsor
Assiut University
Responsible party
Dalia Abdo Abdelhafez Sayed (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 8, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Nov 26, 2027 (estimated)
Completion
Jul 20, 2028 (estimated)
Last update
Oct 29, 2026

Study contacts

Dalia a Sayed, Resident
Contact
Dalia.18331747@med.aun.edu.eg
+20 11 54130609
Mohamed M Hamdy, 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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