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Nipple Areola Complex Conservation

This study has been completed.

Sponsored by: Technische Universität München
Information provided by: Technische Universität München
ClinicalTrials.gov Identifier: NCT00641628
  Purpose

96 patients were offered a nipple sparing mastectomy.


Condition Intervention
Breast Cancer
Procedure: mastectomy

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Mastectomy   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • tumour recurrence [ Time Frame: 07/2003 - 02/2008 ]
  • % of nipple areola complex conservation [ Time Frame: 07/2003 - 02/2008 ]

Secondary Outcome Measures:
  • cosmetics
  • patient's satisfaction

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Breast Carcinoma Tissue


Study Start Date:   July 2003
Study Completion Date:   May 2006
Primary Completion Date:   May 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1 Procedure: mastectomy

Detailed Description:

96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • breast cancer

Exclusion Criteria:

  • inflammatory breast cancer
  • clinical skin or nipple involvement
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641628

Locations
Germany
Klinikum rechts der Isar    
      Munich, Germany, 81675

Sponsors and Collaborators
Technische Universität München

Investigators
Study Chair:     Marion Kiechle, MD     Technische Universität München    
  More Information


Responsible Party:   Technical University of Munich ( Stefan Paepke, MD )
Study ID Numbers:   NAC01
First Received:   March 19, 2008
Last Updated:   March 19, 2008
ClinicalTrials.gov Identifier:   NCT00641628
Health Authority:   Germany: Munich Cancer Registery (MCR)

Keywords provided by Technische Universität München:
Nipple sparing mastectomy  
NAC conservation  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 17, 2008




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