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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:

U.S. FDA Resources

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
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013