Search for Predictive Markers of Efficacy of ESAs in Patients With Non-myeloid Malignancies or Myelodysplastic Syndrome

NCT ID: NCT01546337

Last Updated: 2012-03-07

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

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-11-30

Brief Summary

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Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

Detailed Description

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Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. Thus, only 50-60% of patients with multiple myeloma or non-Hodgkin lymphoma respond to ESAs. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.

Conditions

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Myelodysplastic Syndromes Anemia Hemopathies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18
* patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
* indication of ESAs therapy with Hb \< 11g/dl

Exclusion Criteria

* uncontrolled hypertension
* anemia due to deficiency
* pregnant and lactating women
* patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Escoffre-Barbe Martine, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Laviolle Bruno, MD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

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Laval Hospital

Laval, , France

Site Status

Rennes University Hospital

Rennes, , France

Site Status

Yves Le Foll Hospital

Saint-Brieuc, , France

Site Status

Saint-Malo Hospital

St-Malo, , France

Site Status

Bretagne Atlantic Hospital

Vannes, , France

Site Status

Countries

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France

Other Identifiers

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CCTIRS908111

Identifier Type: -

Identifier Source: org_study_id

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