- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641628
Nipple Areola Complex Conservation
March 19, 2008 updated by: Technical University of Munich
Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications
96 patients were offered a nipple sparing mastectomy.
Study Overview
Detailed Description
96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Munich, Germany, 81675
- Klinikum Rechts der Isar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- breast cancer
Exclusion Criteria:
- inflammatory breast cancer
- clinical skin or nipple involvement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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tumour recurrence
Time Frame: 07/2003 - 02/2008
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07/2003 - 02/2008
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% of nipple areola complex conservation
Time Frame: 07/2003 - 02/2008
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07/2003 - 02/2008
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Secondary Outcome Measures
Outcome Measure |
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cosmetics
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patient's satisfaction
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Marion Kiechle, MD, Technical University of Munich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
March 19, 2008
First Submitted That Met QC Criteria
March 19, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
March 24, 2008
Last Update Submitted That Met QC Criteria
March 19, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- NAC01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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