Breast CancerNCT00641628
Nipple Areola Complex Conservation
An observational study of Breast Cancer, run by Technical University of Munich at 1 site in Germany.
Trial summary
96 patients were offered a nipple sparing mastectomy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jul 2003to May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- breast cancer
Who cannot join
- inflammatory breast cancer
- clinical skin or nipple involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications
96 patients were offered a nipple sparing mastectomy.
Read the detailed description
96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.
- Conditions
- Breast Cancer
- Being tested
- mastectomy
- Keywords
- Nipple sparing mastectomy, NAC conservation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mastectomyProcedure or surgery
Also called breast surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumour recurrence
Measured: 07/2003 - 02/2008
% of nipple areola complex conservation
Measured: 07/2003 - 02/2008
Secondary outcomes (2)
cosmetics
patient's satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJul 2003
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Marion Kiechle, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641628
- Sponsor's protocol ID
- NAC01
- Status last verified
- Mar 2008
- First submitted
- 19 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1097/SLA.0b013e3181b0c7d8.
PubMed 19638905
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Mastectomy With Conservation of the Nipple Areola Complex: Broadening the Indications
- ClinicalTrials.gov ID
- NCT00641628
- Acronym / sponsor ID
- NAC01
- Conditions
- Breast Cancer
- Keywords
- Nipple sparing mastectomy, NAC conservation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
96 patients were offered a nipple sparing mastectomy.
Detailed description
96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: mastectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- breast cancer
Key exclusion criteria (2 listed)
- inflammatory breast cancer
- clinical skin or nipple involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mastectomyAlso: breast surgery | Procedure or surgery | 1 |
Primary outcome
tumour recurrence
Time frame: 07/2003 - 02/2008
% of nipple areola complex conservation
Time frame: 07/2003 - 02/2008
2 secondary outcomes
cosmetics
patient's satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
- Derived from this study: PubMed 19638905Paepke 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. doi: 10.1097/SLA.0b013e3181b0c7d8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Kiechle, MD study chair
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumour recurrence (time frame: 07/2003 - 02/2008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2008.