NCT01546337

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

5 active sites

Status
terminated

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

Study Start

First participant enrolled

May 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 1, 2012

Last Update Submit

March 6, 2012

Conditions

Myelodysplastic SyndromesAnemiaHemopathies

Keywords

anemianon-myeloid haemopathymyelodysplastic syndromeErythropoiesis stimulating agentspredictive markers

Outcome Measures

Primary Outcomes (1)

  • response to erythropoietin

    * Complete response : increase of 2g/dl of erythropoietin rate or stopping of transfusion requirements. * Partial response : increase of 1 to 2g/dl rate of erythropoietin or 50% reduction of transfusion requirements.

    12 weeks

Secondary Outcomes (3)

  • endogenous erythropoietin rate

    Within 8 days before inclusion

  • hemoglobin rate

    Weeks 0,4,8 and 12

  • Number of transfusions during the duration of the study

    12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment

You may qualify if:

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

You may not qualify if:

  • uncontrolled hypertension
  • anemia due to deficiency
  • pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Laval Hospital

Laval, 53015, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Yves Le Foll Hospital

Saint-Brieuc, 22027, France

Location

Saint-Malo Hospital

St-Malo, 35403, France

Location

Bretagne Atlantic Hospital

Vannes, 56017, France

Location

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemia

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Escoffre-Barbe Martine, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Laviolle Bruno, MD

    Rennes University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

FR(5)