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Nipple Areola Complex Conservation

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00641628
First received: March 19, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

96 patients were offered a nipple sparing mastectomy.


Condition Intervention
Breast Cancer
Procedure: mastectomy

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

Resource links provided by NLM:


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

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
Other Name: breast surgery

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
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: 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

No publications provided by Technische Universität München

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Paepke, MD, Technical University of Munich
ClinicalTrials.gov Identifier: NCT00641628     History of Changes
Other Study ID Numbers: NAC01
Study First Received: March 19, 2008
Last Updated: March 19, 2008
Health Authority: Germany: Munich Cancer Registery (MCR)

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

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

ClinicalTrials.gov processed this record on November 20, 2014