Spanish Registry of Erythropoietic Stimulating Agents Study (SPRESAS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Grupo Español de Síndromes Mielodisplásicos
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Síndromes Mielodisplásicos
ClinicalTrials.gov Identifier:
NCT01739452
First received: November 29, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition
Myelodysplastic Syndrome

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Grupo Español de Síndromes Mielodisplásicos:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 900
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)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739452

Contacts
Contact: Guillermo Sanz, MD +34 93 434 44 12 secretaria@gesmd.org

Sponsors and Collaborators
Grupo Español de Síndromes Mielodisplásicos
Investigators
Study Chair: Maria Consuelo Cañizo, MD Hospital Universitario de Salamanca
Study Chair: María Díez, MD Hospital Universitario de Salamanca
  More Information

No publications provided

Responsible Party: Grupo Español de Síndromes Mielodisplásicos
ClinicalTrials.gov Identifier: NCT01739452     History of Changes
Other Study ID Numbers: GESMD-SPRESAS-2012-01
Study First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Síndromes Mielodisplásicos:
Low-risk MDS
myelodysplastic syndrome
retrospective

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014