Tumour Registry Breast Cancer (TMK)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT01351584
First received: May 9, 2011
Last updated: July 7, 2016
Last verified: July 2016

May 9, 2011
July 7, 2016
February 2007
June 2019   (final data collection date for primary outcome measure)
Course of Antineoplastic Treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Course of Antineoplastic Treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01351584 on ClinicalTrials.gov Archive Site
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Tumour Registry Breast Cancer
Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany
The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

The impact of nutrition (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Breast cancer patients undergoing antineoplastic or antihormonal therapy.
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4500
December 2020
June 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Breast cancer
  • 18 years and older
  • Antineoplastic or antihormonal treatment

Exclusion Criteria:

  • No breast cancer
  • Below 18 years
  • No antineoplastic or antihormonal treatment
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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Germany
 
NCT01351584
IOM TMK, Tumorregister Mammakarzinom
No
No
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iOMEDICO AG
iOMEDICO AG
  • Arbeitskreis Klinische Studien
  • Arbeitsgemeinschaft fur Internistische Onkologie
Study Chair: Hans Tesch, MD
iOMEDICO AG
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP