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

NCT ID: NCT05204953

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-04-30

Brief Summary

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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

Detailed Description

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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 .

Conditions

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Myelodysplastic Syndromes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

patients diagnosed to have myelodysplastic syndrome

No interventions assigned to this group

2

healthy control subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients diagnosed to have myelodysplastic syndromes

Exclusion Criteria

* no
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nady Hussein

Consultant of Clinical Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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youssreya A Ahmad, MD

Role: STUDY_DIRECTOR

Assiut University

Ahmad F Thabet, MD

Role: STUDY_DIRECTOR

Assiut University

References

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Tefferi A, Lim KH, Levine R. Mutation in TET2 in myeloid cancers. N Engl J Med. 2009 Sep 10;361(11):1117; author reply 1117-8. doi: 10.1056/NEJMc091348. No abstract available.

Reference Type BACKGROUND
PMID: 19741235 (View on PubMed)

Greenberg PL, Attar E, Bennett JM, Bloomfield CD, De Castro CM, Deeg HJ, Foran JM, Gaensler K, Garcia-Manero G, Gore SD, Head D, Komrokji R, Maness LJ, Millenson M, Nimer SD, O'Donnell MR, Schroeder MA, Shami PJ, Stone RM, Thompson JE, Westervelt P; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: myelodysplastic syndromes. J Natl Compr Canc Netw. 2011 Jan;9(1):30-56. doi: 10.6004/jnccn.2011.0005.

Reference Type BACKGROUND
PMID: 21233243 (View on PubMed)

Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Sole F, Bennett JM, Bowen D, Fenaux P, Dreyfus F, Kantarjian H, Kuendgen A, Levis A, Malcovati L, Cazzola M, Cermak J, Fonatsch C, Le Beau MM, Slovak ML, Krieger O, Luebbert M, Maciejewski J, Magalhaes SM, Miyazaki Y, Pfeilstocker M, Sekeres M, Sperr WR, Stauder R, Tauro S, Valent P, Vallespi T, van de Loosdrecht AA, Germing U, Haase D. Revised international prognostic scoring system for myelodysplastic syndromes. Blood. 2012 Sep 20;120(12):2454-65. doi: 10.1182/blood-2012-03-420489. Epub 2012 Jun 27.

Reference Type BACKGROUND
PMID: 22740453 (View on PubMed)

Foran JM, Shammo JM. Clinical presentation, diagnosis, and prognosis of myelodysplastic syndromes. Am J Med. 2012 Jul;125(7 Suppl):S6-13. doi: 10.1016/j.amjmed.2012.04.015.

Reference Type BACKGROUND
PMID: 22735753 (View on PubMed)

Johnston TC, Thompson RB, Baldwin TO. Nucleotide sequence of the luxB gene of Vibrio harveyi and the complete amino acid sequence of the beta subunit of bacterial luciferase. J Biol Chem. 1986 Apr 15;261(11):4805-11.

Reference Type BACKGROUND
PMID: 3514602 (View on PubMed)

Mittelman M, Oster HS, Hoffman M, Neumann D. The lower risk MDS patient at risk of rapid progression. Leuk Res. 2010 Dec;34(12):1551-5. doi: 10.1016/j.leukres.2010.05.023. Epub 2010 Jun 22.

Reference Type BACKGROUND
PMID: 20573398 (View on PubMed)

Other Identifiers

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PVARMDS

Identifier Type: -

Identifier Source: org_study_id

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