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Nipple Areola Complex Conservation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641628
First Posted: March 24, 2008
Last Update Posted: March 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 19, 2008
First Posted: March 24, 2008
Last Update Posted: March 24, 2008
Last Verified: March 2008

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