The Role of Erythropoietin in Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00723112|
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : November 23, 2010
|Condition or disease|
Myelodysplastic syndromes are a heterogeneous group of disorders characterized by clonal expansion of hematopoietic stem cells and ineffective hematopoiesis. Although all 3 cell lineages in myeloid hematopoiesis can be involved, the erythroid dysplasia and ineffective erythropoiesis of MDS are usually the most severe, and often precede the development of other bone marrow lineage defects.
In normal erythropoiesis, erythroid progenitors differentiate and proliferate in response to stimulation by erythropoietin (Epo). Epo binds to its receptor, EpoR, constitutively expressed at the surface of committed erythroid progenitors and induces homodimerization. This study is designed to evaluate the EpoR cDNA sequence and its level of expression in the clonal erythroid progenitors of MDS patients (in cells stratified for the same degree of erythroid maturation) to determine whether mutations in the EpoR may be responsible for an aberrant Epo signal transduction in MDS. As well as analyze intrinsic erythroid Epo expression to determine whether it differs between normal controls and patients with MDS and perform a microarray analysis of genes associated with Epo signal transduction to determine if MDS patients have abnormal expression of signal transduction proteins.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Observational Model:||Case Control|
|Official Title:||The Role of Erythropoietin in Myelodysplastic Syndrome|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Adult subjects with the diagnosis of MDS based on the French-American-British classification system.
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
- 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 ]
- Analyze intrinsic erythroid Epo expression to determine whether it differs between normal controls and patients with MDS. [ Time Frame: After samples are obtained ]
- 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 ]
- Determine how often and what percent clonality occurs in MDS patients and try to predict who has early MDS by clonality testing. [ Time Frame: After samples from female patients have been obtained ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723112
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|VA Salt Lake City Health Care System|
|Salt lake City, Utah, United States, 84148|
|Principal Investigator:||Josef T Prchal, MD||University of Utah|