Prognostic Value of Serum Erythropoietin Level,Ferritin Level and Fibrinogen in Adult Low Risk MDS

NCT04573686 | Unknown

• 1 other identifier: MDS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.assessment of the penefit of erythropoietin administration in decreasing the frequency of blood transfusion in adult low risk MDS
2. 2.assessement of the clinical significance of the relationship between hyperfibrinogenemia and the prognosis of patients with low risk MDS
3. 3.assessement of the association between serum ferritin levels and patient \_reported aspects and symptomes

Conditions

MDS

Outcome Measures

Primary Outcomes (1)

• effect of erythropoietin on MDS prognosis

  1 year

Interventions

Erythropoietin DRUG

Erythropoietin will be given subcutenous to all patients

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

the participants are :adult low risk(IPSS score (2-3) myelodysplastic patients with median age (40-60)

You may qualify if:

• the participants are :adult low risk(IPSS score (2-3) myelodysplastic patients with median age (40-60)

You may not qualify if:

• patients with hiigh and intermediate risk MDS

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Gangat N, Patnaik MM, Tefferi A. Myelodysplastic syndromes: Contemporary review and how we treat. Am J Hematol. 2016 Jan;91(1):76-89. doi: 10.1002/ajh.24253.

  PMID: 26769228 BACKGROUND

• Tefferi A, Vardiman JW. Myelodysplastic syndromes. N Engl J Med. 2009 Nov 5;361(19):1872-85. doi: 10.1056/NEJMra0902908. No abstract available.

  PMID: 19890130 BACKGROUND

• Vardiman JW, Harris NL, Brunning RD. The World Health Organization (WHO) classification of the myeloid neoplasms. Blood. 2002 Oct 1;100(7):2292-302. doi: 10.1182/blood-2002-04-1199.

  PMID: 12239137 BACKGROUND

• Cazzola M, Barosi G, Berzuini C, Dacco M, Orlandi E, Stefanelli M, Ascari E. Quantitative evaluation of erythropoietic activity in dysmyelopoietic syndromes. Br J Haematol. 1982 Jan;50(1):55-62. doi: 10.1111/j.1365-2141.1982.tb01890.x.

  PMID: 6948570 BACKGROUND

• Della Porta MG, Malcovati L, Strupp C, Ambaglio I, Kuendgen A, Zipperer E, Travaglino E, Invernizzi R, Pascutto C, Lazzarino M, Germing U, Cazzola M. Risk stratification based on both disease status and extra-hematologic comorbidities in patients with myelodysplastic syndrome. Haematologica. 2011 Mar;96(3):441-9. doi: 10.3324/haematol.2010.033506. Epub 2010 Dec 6.

  PMID: 21134982 BACKGROUND

• Stasi R, Abruzzese E, Lanzetta G, Terzoli E, Amadori S. Darbepoetin alfa for the treatment of anemic patients with low- and intermediate-1-risk myelodysplastic syndromes. Ann Oncol. 2005 Dec;16(12):1921-7. doi: 10.1093/annonc/mdi400. Epub 2005 Sep 15.

  PMID: 16166176 BACKGROUND

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-09