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.
18 Years
N/A
Both
Myelodysplastic Syndrome
Trial Information
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pretreatment of SMD with hypomethylating agents, lenalidomide, chemotherapy, other.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Retrospective
Outcome Measure:
Collect and evaluate the Spanish experience of anemia treatment.
Outcome Description:
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.
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Maria Consuelo Cañizo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hospital Universitario de Salamanca
Authority:
Spain: Spanish Agency of Medicines
Study ID:
GESMD-SPRESAS-2012-01
NCT ID:
NCT01739452
Start Date:
January 2013
Completion Date:
September 2013
Related Keywords:
- Myelodysplastic Syndrome
- Low-risk MDS
- myelodysplastic syndrome
- retrospective
- Myelodysplastic Syndromes
- Preleukemia
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