NCT01795690

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,018

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 29, 2016

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

October 8, 2012

Last Update Submit

February 26, 2016

Conditions

Anemia

Keywords

AnemiaCancerHemoglobinQuality of LifeFACT-AnFACT-GPErythropoiesis-Stimulating Agents (ESA)EpoetinFerric CarboxymaltoseBlood Transfusions

Outcome Measures

Primary Outcomes (1)

  • Documentation of therapies

    Overview on the current routine treatment of anemia in cancer patients in Germany

    12 weeks per patient

Secondary Outcomes (1)

  • Change in hemoglobin levels and QoL

    12 weeks per patient

Eligibility Criteria

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

Patients with malignant diseases starting anti-anemic treatment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iOMEDICO

Freiburg im Breisgau, 79108, Germany

Location

Related Publications (1)

  • Steinmetz T, Schroder J, Plath M, Link H, Vogt M, Frank M, Marschner N. Antianemic Treatment of Cancer Patients in German Routine Practice: Data from a Prospective Cohort Study-The Tumor Anemia Registry. Anemia. 2016;2016:8057650. doi: 10.1155/2016/8057650. Epub 2016 Feb 4.

    PMID: 26966573RESULT

MeSH Terms

Conditions

AnemiaNeoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2012

First Posted

February 21, 2013

Study Start

December 1, 2011

Primary Completion

September 1, 2013

Study Completion

February 1, 2016

Last Updated

February 29, 2016

Record last verified: 2014-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)