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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204953
• Other study ID #: PVARMDS
• Status: Completed
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients diagnosed to have myelodysplastic syndromes

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Solé 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, Pfeilstöcker 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. Epub 2012 Jun 27. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean platelet volume		at diagnosis (baseline)
Secondary	risk stratification of MDS patients		at diagnosis (baseline)
Secondary	relation of MPV to risk stratification		at diagnosis (baseline)