Spanish Registry of Erythropoietic Stimulating Agents Study (SPRESAS)
Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||National Registry of Patients Diagnosed With Low-risk Myelodysplastic Syndromes According to the Criteria of the WHO / French-American-British Classification System (FAB) and IPSS and Treated With Erythropoietic Agents.|
- Collect and evaluate the Spanish experience of anemia treatment. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Collect and evaluate retrospectively the Spanish experience of anemia treatment in patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1) evaluating the efficacy and safety of treatment with ESAs received for at least 24 weeks and the evolution of a control group of patients who received only transfusional support.
- Duration of response [ Time Frame: 6 months ] [ Designated as safety issue: No ]In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment.
- Overall survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluate overall survival in the two groups of patients, support transfusional versus ESA.
- Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Security: To determine the frequency, type, intensity and severity of adverse events and their possible relationship with the various ESA and progression to acute myelogenous leukemia.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents.
A control group of patients who received only transfusional support.
Review of RESMD data base in the group of patients with MDS from diagnosis of low risk myelodysplastic syndrome (MDS) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (ESAs) / support transfusional before December 31, 2011. In all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739452
|Contact: Guillermo Sanz, MD||+34 93 434 44 firstname.lastname@example.org|
|Study Chair:||Maria Consuelo Cañizo, MD||Hospital Universitario de Salamanca|
|Study Chair:||María Díez, MD||Hospital Universitario de Salamanca|