Clinical Tumor Anemia Registry (TAR)

Anemia Clinical Trial

— TAR  

Official title:

Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795690
• Other study ID #: iOM TAR
• Status: Completed
• Phase: N/A
• First received: October 8, 2012
• Last updated: February 26, 2016
• Start date: December 2011
• Est. completion date: February 2016

Study information

• Verified date: December 2014
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1018
• Est. completion date: February 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
Germany	iOMEDICO	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
iOMEDICO AG	ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Tilman Steinmetz, Jan Schröder, Margarete Plath, et al., "Antianemic Treatment of Cancer Patients in German Routine Practice: Data from a Prospective Cohort Study—The Tumor Anemia Registry," Anemia, vol. 2016, Article ID 8057650, 9 pages, 2016. doi:10.115

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of therapies	Overview on the current routine treatment of anemia in cancer patients in Germany	12 weeks per patient	No
Secondary	Change in hemoglobin levels and QoL	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.	12 weeks per patient	No

External Links

•   Study Results