The Role of Erythropoietin in Myelodysplastic Syndrome - Full Text View

Purpose

The purpose of the study is to elucidate the causative molecular events responsible for the abnormal erythropoiesis in MDS.

Condition

Myelodysplastic Syndrome

Drug Information available for:

Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	The Role of Erythropoietin in Myelodysplastic Syndrome

Further study details as provided by University of Utah:

Primary Outcome Measures:

Evaluate the EPOR cDNA sequence and its level of expression in the clonal erythroid progenitors of MDS patients to determine whether mutations in the EPOR may be responsible for an aberrant Epo signal transduction in MDS. [ Time Frame: After Samples are obtained ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Analyze intrinsic erythroid Epo expression to determine whether it differs between normal controls and patients with MDS. [ Time Frame: After samples are obtained ] [ Designated as safety issue: No ]
Perform a microarray analysis of genes associated with Epo signal transduction to determine if MDS patients have abnormal expression of signal transduction proteins. [ Time Frame: After samples are obtained ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

Affected Group

Adult subjects with the diagnosis of MDS based on the French-American-British classification system.

Healthy Controls

Control subjects will be selected using frequency matching on gender and age by decade. That is for each MDS patient a healthy volunteer of the same gender and decade (50-59, 60-69, 70-79, etc) will be selected

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects diagnosed with myelodysplastic syndrome

Criteria

Inclusion Criteria:

Adult subjects greater than 18 years of age
Diagnosis of MDS based on the French-American-British classification system (including secondary causes of MDS)

Exclusion Criteria:

Subjects not meeting the criteria listed above

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723112

Contacts


Contact: Josef T Prchal, MD	801-581-4220	josef.prchal@hsc.utah.edu

Contact: Heather Gilbert, MD	801-585-0127	heather.gilbert@hci.utah.edu

Locations


United States, Utah
	University of Utah	Recruiting
	Salt Lake City, Utah, United States, 84132
	Contact: Josef T Prchal, MD 801-581-4220 josef.prchal@hsc.utah.edu
	Contact: Heather Gilbert, MD 801-585-0127 heather.gilbert@hci.utah.edu
	Principal Investigator: Josef T Prchal, MD
	Sub-Investigator: Heather Gilbert, MD
	VA Salt Lake City Health Care System	Recruiting
	Salt lake City, Utah, United States, 84148
	Contact: Josef T Prchal, MD 801-581-4220 josef.prchal@hsc.utah.edu
	Contact: Heather Gilbert, MD 801-585-0127 heather.gilbert@hci.utah.edu
	Principal Investigator: Josef T Prchal, MD
	Sub-Investigator: Heather Gilbert, MD

Sponsors and Collaborators

University of Utah

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Josef T Prchal, MD	University of Utah

More Information

Publications:

Aul C, Arning M, Runde V, Schneider W. Serum erythropoietin concentrations in patients with myelodysplastic syndromes. Leuk Res. 1991;15(7):571-5.

Stasi R, Brunetti M, Terzoli E, Abruzzese E, Amadori S. Once-weekly dosing of recombinant human erythropoietin alpha in patients with myelodysplastic syndromes unresponsive to conventional dosing. Ann Oncol. 2004 Nov;15(11):1684-90.

Casadevall N, Durieux P, Dubois S, Hemery F, Lepage E, Quarre MC, Damaj G, Giraudier S, Guerci A, Laurent G, Dombret H, Chomienne C, Ribrag V, Stamatoullas A, Marie JP, Vekhoff A, Maloisel F, Navarro R, Dreyfus F, Fenaux P. Health, economic, and quality-of-life effects of erythropoietin and granulocyte colony-stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood. 2004 Jul 15;104(2):321-7. Epub 2004 Mar 30.

Solignac M; European Hematology Association. [Epoetin beta, new strategies to optimise the management of anaemia in cancer patients] Presse Med. 2003 Sep 13;32(29):1385-8. French. No abstract available.

Fontenay-Roupie M, Bouscary D, Guesnu M, Picard F, Melle J, Lacombe C, Gisselbrecht S, Mayeux P, Dreyfus F. Ineffective erythropoiesis in myelodysplastic syndromes: correlation with Fas expression but not with lack of erythropoietin receptor signal transduction. Br J Haematol. 1999 Aug;106(2):464-73.

Takeshita A, Shinjo K, Naito K, Ohnishi K, Higuchi M, Ohno R. Erythropoietin receptor in myelodysplastic syndrome and leukemia. Leuk Lymphoma. 2002 Feb;43(2):261-4. Review.

Shinjo K, Takeshita A, Higuchi M, Ohnishi K, Ohno R. Erythropoietin receptor expression on human bone marrow erythroid precursor cells by a newly-devised quantitative flow-cytometric assay. Br J Haematol. 1997 Mar;96(3):551-8.

McMullin MF, Percy MJ. Erythropoietin receptor and hematological disease. Am J Hematol. 1999 Jan;60(1):55-60. Review.

Kralovics R, Sokol L, Broxson EH Jr, Prchal JT. The erythropoietin receptor gene is not linked with the polycythemia phenotype in a family with autosomal dominant primary polycythemia. Proc Assoc Am Physicians. 1997 Nov;109(6):580-5.

Kralovics R, Indrak K, Stopka T, Berman BW, Prchal JF, Prchal JT. Two new EPO receptor mutations: truncated EPO receptors are most frequently associated with primary familial and congenital polycythemias. Blood. 1997 Sep 1;90(5):2057-61.

Stopka T, Zivny JH, Stopkova P, Prchal JF, Prchal JT. Human hematopoietic progenitors express erythropoietin. Blood. 1998 May 15;91(10):3766-72.

Sato TN. A new role of lipid receptors in vascular and cardiac morphogenesis. J Clin Invest. 2000 Oct;106(8):939-40. No abstract available.

Responsible Party:	University of Utah ( Josef T. Prchal, MD )
Study ID Numbers:	20716, DK007115-31
First Received:	July 24, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00723112
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Myelodysplastic Syndrome

Erythropoiesis

Ineffective Hematopoiesis

Erythroid Progenitors

Dyserythropoiesis

Study placed in the following topic categories:

Epoetin Alfa

Myelodysplastic syndromes

Preleukemia

Precancerous Conditions

Hematologic Diseases

Myelodysplasia

Myelodysplastic Syndromes

Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	University of Utah National Institutes of Health (NIH)
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00723112