Nipple Areola Complex Conservation - Full Text View

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

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

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

No publications provided by Technische Universität München

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Paepke S, Schmid R, Fleckner S, Paepke D, Niemeyer M, Schmalfeldt B, Jacobs VR, Kiechle M. Subcutaneous mastectomy with conservation of the nipple-areola skin: broadening the indications. Ann Surg. 2009 Aug;250(2):288-92.

Responsible Party:	Technical University of Munich ( Stefan Paepke, MD )
Study ID Numbers:	NAC01
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00641628 History of Changes
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
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009