Mean Platelet Volume and Its Relation to Risk Stratification of Myelodysplastic Syndromes

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05204953
Collaborator
(none)
71
18

Study Details

Study Description

Brief Summary

The myelodysplastic syndromes (MDS) are a group of myeloid neoplasms characterized by abnormal differentiation and maturation of myeloid cells, reduced bone marrow (BM) function, and a genetic instability with enhanced risk to transform to secondary acute myeloid leukemia, AML

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The diagnosis of MDS is an effort that requires clinicians and pathologists to work together. A patient's life, livelihood and outlook can be profoundly affected by the terms used by the treating physician. The typical presentation is unexplained anemia, leukopenia and/or thrombocytopenia, in an older patients (median age ≥ 70 years). However, thrombocytosis may be associated with the 5q-deletion syndrome or in selected patients with refractory anemia with ringed sideroblasts syndrome . The white count may be elevated in MDS / myeloproliferative disorder overlap syndromes particularly in chronic myelomonocytic leukemia, CMML.

    MDS remains among the most challenging of the myeloid neoplasms to diagnose and classify, particularly in cases in which the blast percentage is not increased in the peripheral blood or bone marrow. Diagnostic problems can arise when the clinical and laboratory findings suggest MDS, but the morphologic findings are inconclusive; when there is secondary dysplasia caused by nutritional deficiencies, medications, toxins, growth factor therapy, inflammation or infection; or when marrow hypocellularity or myelofibrosis obscures the underlying disease process .

    The prognosis of MDS is determined by several factors. Revised International Prognostic Scoring System (IPSS-R) for MDS divides patients into very low, low, intermediate, high and very high risk groups. Five factors (the percentage of bone marrow myeloblasts, the diagnostic cytogenetics, the hemoglobin level, the platelet count and the absolute neutrophilic count) are used to generate a prognostic score .

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    71 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Mean Platelet Volume and Its Relation to Risk Stratification of Myelodysplastic Syndromes
    Actual Study Start Date :
    Oct 1, 2013
    Actual Primary Completion Date :
    Oct 1, 2014
    Actual Study Completion Date :
    Apr 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    1

    patients diagnosed to have myelodysplastic syndrome

    2

    healthy control subjects

    Outcome Measures

    Primary Outcome Measures

    1. mean platelet volume [at diagnosis (baseline)]

    Secondary Outcome Measures

    1. risk stratification of MDS patients [at diagnosis (baseline)]

    2. relation of MPV to risk stratification [at diagnosis (baseline)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All patients diagnosed to have myelodysplastic syndromes
    Exclusion Criteria:
    • no

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: youssreya A Ahmad, MD, Assiut University
    • Study Director: Ahmad F Thabet, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Asmaa Nady Hussein, Consultant of Clinical Hematology, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05204953
    Other Study ID Numbers:
    • PVARMDS
    First Posted:
    Jan 24, 2022
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 24, 2022