- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351584
Tumour Registry Breast Cancer (TMK)
Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Course of Antineoplastic Treatment
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hans Tesch, MD
Publications and helpful links
General Publications
- Fietz T, Tesch H, Rauh J, Boller E, Kruggel L, Janicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Palliative systemic therapy and overall survival of 1,395 patients with advanced breast cancer - Results from the prospective German TMK cohort study. Breast. 2017 Aug;34:122-130. doi: 10.1016/j.breast.2017.05.014. Epub 2017 Jun 3.
- Schroder J, Fietz T, Kohler A, Petersen V, Tesch H, Spring L, Fleitz A, Janicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Treatment and pattern of bone metastases in 1094 patients with advanced breast cancer - Results from the prospective German Tumour Registry Breast Cancer cohort study. Eur J Cancer. 2017 Jul;79:139-148. doi: 10.1016/j.ejca.2017.03.031. Epub 2017 May 8.
- Hurtz HJ, Tesch H, Gohler T, Hutzschenreuter U, Harde J, Kruggel L, Janicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Persistent impairments 3 years after (neo)adjuvant chemotherapy for breast cancer: results from the MaTox project. Breast Cancer Res Treat. 2017 Oct;165(3):721-731. doi: 10.1007/s10549-017-4365-7. Epub 2017 Jul 5.
- Fietz T, Zahn MO, Kohler A, Engel E, Frank M, Kruggel L, Janicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Routine treatment and outcome of breast cancer in younger versus elderly patients: results from the SENORA project of the prospective German TMK cohort study. Breast Cancer Res Treat. 2018 Jan;167(2):567-578. doi: 10.1007/s10549-017-4534-8. Epub 2017 Oct 13.
- Dorfel S, Steffens CC, Meyer D, Tesch H, Kruggel L, Frank M, Janicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Adjuvant chemotherapeutic treatment of 1650 patients with early breast cancer in routine care in Germany: data from the prospective TMK cohort study. Breast Cancer. 2018 May;25(3):275-283. doi: 10.1007/s12282-017-0823-7. Epub 2017 Dec 4.
- Marschner N, Trarbach T, Rauh J, Meyer D, Muller-Hagen S, Harde J, Dille S, Kruggel L, Janicke M; TMK-Group (Tumour Registry Breast Cancer). Quality of life in pre- and postmenopausal patients with early breast cancer: a comprehensive analysis from the prospective MaLife project. Breast Cancer Res Treat. 2019 Jun;175(3):701-712. doi: 10.1007/s10549-019-05197-w. Epub 2019 Mar 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOM TMK
- Tumorregister Mammakarzinom (Other Identifier: iOMEDICO AG)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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