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

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

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes

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 Type: Observational
• Enrollment (Actual): 71

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed to have myelodysplastic syndromes

Description

Inclusion Criteria:

• All patients diagnosed to have myelodysplastic syndromes

Exclusion Criteria:

• no

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; patients diagnosed to have myelodysplastic syndrome
2; healthy control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean platelet volume	at diagnosis (baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
risk stratification of MDS patients	at diagnosis (baseline)
relation of MPV to risk stratification	at diagnosis (baseline)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: PVARMDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No