Spanish Registry of Erythropoietic Stimulating Agents Study
SPRESAS
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.
1 other identifier
observational
722
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2012
CompletedFirst Posted
Study publicly available on registry
December 3, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 13, 2018
April 1, 2015
1.3 years
November 29, 2012
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collect and evaluate the Spanish experience of anemia treatment.
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.
6 months
Secondary Outcomes (3)
Duration of response
6 months
Overall survival.
6 months
Adverse events
6 months
Study Arms (2)
erythropoiesis-stimulating agents
Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents.
Transfusion support
A control group of patients who received only transfusional support.
Eligibility Criteria
Patients diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL) and treatment (support / ESA) started before December 31, 2011.
You may qualify if:
- The patient has given consent to the collection of data in the RESMD.
- Age ≥ 18 years.
- Patient must be diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL).
- The patient has studies at the time of diagnosis discard the possibility that MDS anemia is due to deficiency of factors (iron, vitamin B12 or folic acid).
- Initiation of treatment with ESAs or support transfusional at any spanish hematology service before December 31, 2011.
You may not qualify if:
- Pretreatment of SMD with hypomethylating agents, lenalidomide, chemotherapy, other.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Consuelo Cañizo, MD
University of Salamanca
- STUDY CHAIR
María Díez, MD
University of Salamanca
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2012
First Posted
December 3, 2012
Study Start
January 1, 2013
Primary Completion
May 1, 2014
Study Completion
September 1, 2014
Last Updated
August 13, 2018
Record last verified: 2015-04