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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
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Registry to Present Treatment and Sequences of Treatments in Routine Practice in Germany

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Course of Antineoplastic Treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4500
Study Start Date: February 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
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).

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351584

Sponsors and Collaborators
iOMEDICO AG
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Investigators
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 
Study First Received: May 9, 2011
Last Updated: July 7, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 09, 2016