Myeloproliferative Neoplasms (MPNs)NCT06753279
Clinical Significance of Leukocyte Cell Population Data in Patients With Myeloproliferative Neoplasms (MPNs)
An observational study of Myeloproliferative Neoplasms (MPNs), run by Assiut University.
Trial 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)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myeloproliferative Neoplasms (MPNs)
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: - Patients with MPNs according to the recent WHO classification.
Who may be able to join
- Patients with MPNs according to the recent WHO classification.
Who cannot join
- Patients with other types of myeloid neoplasms and/or not fulfil the WHO criteria for MPNs diagnosis.
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
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 .
- Conditions
- Myeloproliferative Neoplasms (MPNs)
- Keywords
- leukocyte cell
- Medical subject headings
- Myeloproliferative Disorders
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 |
|---|---|---|
| cases | patients with MPNs according to the recent WHO classification | |
| control | normal healthy individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of leukocyte cell in patients with MPNs
Detection of leukocyte cell population data in patients with MPNs
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative Neoplasms (MPNs)Studies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Gamal Taha Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753279
- Sponsor's protocol ID
- leukocyte cell population MPNs
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35747581Camara 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 34184102Hasselbalch 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