Spanish Registry of Erythropoietic Stimulating Agents Study

NCT ID: NCT01739452

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

722 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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erythropoiesis-stimulating agents

Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents.

No interventions assigned to this group

Transfusion support

A control group of patients who received only transfusional support.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Español de Síndromes Mielodisplásicos

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Consuelo Cañizo, MD

Role: STUDY_CHAIR

University of Salamanca

María Díez, MD

Role: STUDY_CHAIR

University of Salamanca

Other Identifiers

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GESMD-SPRESAS-2012-01

Identifier Type: -

Identifier Source: org_study_id

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