NCT00641628

Brief Summary

96 patients were offered a nipple sparing mastectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

Enrollment Period

2.8 years

First QC Date

March 19, 2008

Last Update Submit

March 19, 2008

Conditions

Breast Cancer

Keywords

Nipple sparing mastectomyNAC conservation

Outcome Measures

Primary Outcomes (2)

  • tumour recurrence

    07/2003 - 02/2008

  • % of nipple areola complex conservation

    07/2003 - 02/2008

Secondary Outcomes (2)

  • cosmetics

  • patient's satisfaction

Study Arms (1)

1

Procedure: mastectomy

Interventions

mastectomyPROCEDURE
Also known as: breast surgery
1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer

You may not qualify if:

  • inflammatory breast cancer
  • clinical skin or nipple involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19638905DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast Carcinoma Tissue

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MastectomyMastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Marion Kiechle, MD

    Technical University of Munich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 24, 2008

Study Start

July 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations

DE(1)