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Not yet recruitingNCT06753279Updated Dec 31, 2024

Clinical Significance of Leukocyte Cell Population Data in Patients with Myeloproliferative Neoplasms (MPNs)

An observational study in Myeloproliferative Neoplasms (MPNs), sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Sex
All
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Study summary

Myeloproliferative neoplasms (MPNs) are a group of clonal hematopoietic disorders which categorized according to the World Health Organization (WHO) into Philadelphia Chromosome positive (Ph +ve) including chronic myeloid leukemia (CML) and Philadelphia Chromosome negative (Ph -ve) like essential thrombocythemia (ET), polycythaemia vera (PV), and primary myelofibrosis (PMF) .

the aim of the study is to Detection of leukocyte cell population data in patients with MPNs and Relation between leukocyte cell population and patients' clinical status.

Read the detailed description

MPNs are characterized by sepsis, thrombosis, myelofibrosis and leukemic transformation as critical complications of the disease. Most recently, the MPNs have been described as "Inflammatory Diseases" because the chronic inflammation being identified as a key factor in the development and progression of the disease . It is characterized by persistent activation of immune cells, elevated leukocyte and platelet counts, release of various mediators, DNA and tissue damage . Consequently. when neutrophils are activated by different stimuli, they undergo degranulation and release neutrophil extracellular traps (NETs) and microparticles, leading to thrombosis in MPNs by blocking blood vessels . Monocyte and its distribution are also a simple marker of activation useful for early sepsis detection .

The leukocyte cell population data (CPD) are parameters used to provide quantitative information on the morphological and functional characteristics of leukocytes. CPD assessment involves measuring neutrophil and monocyte forward scatter (Z axis) for cell size and side scatter (X axis) for internal complexity. Additionally, fluorescence intensity (Y axis) for DNA/RNA content and cell population variability (dispersion width) can also be evaluated.

Therefore, assessing of these parameters in the context of sepsis and thrombosis as a complication of MPNs helps to understand how these conditions interact at the cellular level and provides insights into morphological changes and abnormal leukocyte distribution for early detection and management .

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Conditions studied

  • Myeloproliferative Neoplasms (MPNs)

Keywords

  • leukocyte cell
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 80 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 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
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

  • Patients with MPNs according to the recent WHO classification.

Inclusion criteria

  • Patients with MPNs according to the recent WHO classification.

Exclusion criteria

Exclusion Criteria:

  • Patients with other types of myeloid neoplasms and/or not fulfil the WHO criteria for MPNs diagnosis.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • cases

    patients with MPNs according to the recent WHO classification

  • control

    normal healthy individual

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What researchers measure

Primary outcomes

  1. percentage of leukocyte cell in patients with MPNs

    Detection of leukocyte cell population data in patients with MPNs

    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

  • Mishra S, Chhabra G, Padhi S, Mohapatra S, Panigrahi A, Sable MN, Das PK. Usefulness of Leucocyte Cell Population Data by Sysmex XN1000 Hematology Analyzer in Rapid Identification of Acute Leukemia. Indian J Hematol Blood Transfus. 2022 Jul;38(3):499-507. doi: 10.1007/s12288-021-01488-9. Epub 2021 Sep 28. PubMed 35747581 ↗
  • Camara JE, Wise SA, Hoofnagle AN, Williams EL, Carter GD, Jones J, Burdette CQ, Hahm G, Nalin F, Kuszak AJ, Merkel J, Durazo-Arvizu RA, Lukas P, Cavalier E, Popp C, Beckert C, Schultess J, Van Slooten G, Tourneur C, Pease C, Kaul R, Villarreal A, Ivison F, Fischer R, van den Ouweland JMW, Ho CS, Law EWK, Simard JN, Gonthier R, Holmquist B, Batista MC, Pham H, Bennett A, Meadows S, Cox L, Jansen E, Khan DA, Robyak K, Creer MH, Kilbane M, Twomey PJ, Freeman J, Parker N, Yuan J, Fitzgerald R, Mushtaq S, Clarke MW, Breen N, Simpson C, Sempos CT. Assessment of serum total 25-hydroxyvitamin D assay commutability of Standard Reference Materials and College of American Pathologists Accuracy-Based Vitamin D (ABVD) Scheme and Vitamin D External Quality Assessment Scheme (DEQAS) materials: Vitamin D Standardization Program (VDSP) Commutability Study 2. Anal Bioanal Chem. 2021 Aug;413(20):5067-5084. doi: 10.1007/s00216-021-03470-w. Epub 2021 Jun 28. PubMed 34184102 ↗
  • Hasselbalch HC. Chronic inflammation as a promotor of mutagenesis in essential thrombocythemia, polycythemia vera and myelofibrosis. A human inflammation model for cancer development? Leuk Res. 2013 Feb;37(2):214-20. doi: 10.1016/j.leukres.2012.10.020. Epub 2012 Nov 20. PubMed 23174192 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06753279
Lead sponsor
Assiut University
Responsible party
Ola Gamal Taha Hussein (resident doctor at Assiut University hospital, Assiut University) — Principal investigator
First posted
Dec 31, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Dec 31, 2024

Study contacts

Ola Gamal Taha Hussein, resident doctor
Contact
Ola.16266122@med.aun.edu.eg
+201003196138

Oversight

Data monitoring committee
Yes
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 Dec 2024. You cannot join it, but the record below documents what was studied.

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