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Tumour Registry Breast Cancer (TMK)

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ClinicalTrials.gov Identifier: NCT01351584
Recruitment Status : Active, not recruiting
First Posted : May 11, 2011
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Breast Cancer

Detailed Description:

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).

Study Design

Study Type : Observational
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany
Study Start Date : February 2007
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Course of Antineoplastic Treatment [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients undergoing antineoplastic or antihormonal therapy.

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
Contacts and Locations

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): NCT01351584

Sponsors and Collaborators
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Study Chair: Hans Tesch, MD
More Information

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01351584     History of Changes
Other Study ID Numbers: IOM TMK
Tumorregister Mammakarzinom ( Other Identifier: iOMEDICO AG )
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by iOMEDICO AG:
Breast Cancer
Advanced Breast Cancer
Health Services Research
Palliative Treatment
Adjuvant Drug Therapy
Nutrition Assessment
Physical Activity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases