Text Size

Breast Cancer Registry

This study is currently recruiting participants.
Verified March 2013 by iOMEDICO AG
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: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice in Germany. The registry will follow up patients for three years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. The impact of nutrition (MaNut) and physical activity (MaFit) on the course of the adjuvant disease will be examined, as well as long-term side effects of adjuvant treatment (MaTox). Health-related quality of life will be analysed during the course of the treatment (MaLife). Based on the available data a prognostic score will be developed.


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:

U.S. FDA Resources

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 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351584

Contacts
Contact: Martina Jänicke, PhD +49 761 15242 - 0 info@iomedico.com
Contact: Holger Hartmann, PhD +49 761 15242 - 0 info@iomedico.com

Locations
Germany
iOMEDICO AG Recruiting
Freiburg, BW, Germany
Sponsors and Collaborators
iOMEDICO AG
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Investigators
Study Chair: Hans Tesch, MD
  More Information

No publications provided

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01351584     History of Changes
Other Study ID Numbers: IOM TMK
Study First Received: May 9, 2011
Last Updated: March 26, 2013
Health Authority: Germany: Ethics Commission

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 June 13, 2013