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Clinical Tumor Anemia Registry (TAR) (TAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01795690
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)
Information provided by (Responsible Party):
iOMEDICO AG

Brief Summary:
The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.

Condition or disease
Anemia

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Study Type : Observational
Actual Enrollment : 1018 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia
Study Start Date : December 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia




Primary Outcome Measures :
  1. Documentation of therapies [ Time Frame: 12 weeks per patient ]
    Overview on the current routine treatment of anemia in cancer patients in Germany


Secondary Outcome Measures :
  1. Change in hemoglobin levels and QoL [ Time Frame: 12 weeks per patient ]

    Effectiveness of different antianemic treatments is investigated by measuring increase of hemoglobin levels and QoL (FACT-An and FACT-GP).

    Baseline in hemoglobin (before treatment) is compared with hemoglobin levels after treatment. Each patient is followed for a maximum of 12 weeks to obtain data about the course of the treatment.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with malignant diseases starting anti-anemic treatment
Criteria

Inclusion Criteria:

  • Histologically confirmed malignant disease
  • Hemoglobin level < 11 g/dl (female) or < 12 g/dl (male)
  • Start of antianemic therapy no more than 7 days prior to informed consent
  • Performance status 0 - 3 (Karnofsky-Index >= 40%)
  • Minimum age: 18 years
  • Informed written consent

Exclusion Criteria:

  • Hypersensitivity against antianemic therapies
  • Myelodysplastic Syndrome
  • Experimental antianemic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795690


Locations
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Germany
iOMEDICO
Freiburg, Germany, 79108
Sponsors and Collaborators
iOMEDICO AG
ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)

Additional Information:
Publications of Results:
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01795690     History of Changes
Other Study ID Numbers: iOM TAR
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: December 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
Anemia
Cancer
Hemoglobin
Quality of Life
FACT-An
FACT-GP
Erythropoiesis-Stimulating Agents (ESA)
Epoetin
Ferric Carboxymaltose
Blood Transfusions
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases