SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy (SKINI)

March 20, 2018 updated by: Brust-Zentrum AG

SKINI - Prospective Evaluation of the Radicality of Breast Tissue Removal With Skin-Sparing and Nipple-Sparing Mastectomy (SSM or NSM)

Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective, multi-center trial patients undergoing mastectomy and fulfilling inclusion criteria receive additional biopsies from the remaining skin envelope in order to quantify the amount of residual breast tissue.

Since the investigators will assess, 142 breasts will be investigated. This means a maximum of n=142 patients will be included (corresponding to a minimum of n=71 patient).

On the specimen additional histological sections in radial direction will be performed.

The aim of the study is to evaluate the quality of Skin- Sparing and Nipple-Sparing Mastectomy. On each predefined location in the wound cavity the investigators will investigate where residual breast tissue (RBT) will be found or not. If no RBT can be detected at all predefined breast locations this breast will be classified as having no RBT (=RBT negative). If breast tissue can be detected the investigators have a RBT positive breast.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

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

  • Switzerland
      • Zürich, Switzerland, 8008
        • Brust-Zentrum AG

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergoing uni- or bilateral Skin-Sparing or Nipple-Sparing mastectomy
  • Female participants ≥ 18 years of age
  • The subject was informed on the project and gave her written informed consent to use her data and samples for this project.

Exclusion Criteria:

- Not fulfilling inclusion criteria

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Skin-Sparing Mastectomy (SSM)
Procedure: Skin-Sparing Mastectomy (SSM)

For patients undergoing SSM, 10 points of interest in radial localization have been selected for investigation of the presence of residual breast tissue.

The points are located under the remaining skin envelope and will be investigated by performing small biopsies with a cervical biopsy forceps.

Additionally, the distance between the surface of the specimen and the glandular tissue will be explored at five points at the base of the removed breast.

These histological sections will be radially oriented.
Other: Nipple-Sparing Mastectomy (NSM)
Procedure: Nipple-Sparing Mastectomy (NSM)

For patients undergoing NSM, 14 points of interest in radial localization have been selected for investigation of the presence of residual breast tissue, i.e. comparing to SSM, 4 additional biopsies will be taken behind the peripheral part of the areola.

The points are located under the remaining skin envelope and will be investigated by performing small biopsies with a cervical biopsy forceps.

Additionally, the distance between the surface of the specimen and the glandular tissue will be explored at five points at the base of the removed breast.

These histological sections will be radially oriented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of residual breast tissue (RBT)
Time Frame: 20 months

Each biopsy specimen will be histopathologically assessed for the presence of residual breast tissue (RBT), i.e. in case of SSM 10 biopsy specimens (points A-K) and in case of NSM 14 biopsy specimens (points A-O).

A mastectomy is defined as RBT-positive whenever residual breast tissue will be detected in one or more biopsies. RBT will be assessed as binary dependent variable (0: no RBT; 1: at least one probe with positive breast tissue detection) and correlated with patient- and therapy-related factors, including age, BMI, breast weight, side of mastectomy (left vs. right), type of mastectomy (SSM vs. NSM), skin flap necrosis, indication for mastectomy, axilla surgery, preoperative treatment, surgeon, incision type as well as distance between surface of removed breast and glandular tissue.

Presence of RBT will also be assessed with regard to the distribution within the points A-O and the percentage of RBT-positive biopsies of the entity of all biopsies.
20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance between surface of the removed breast and glandular tissue
Time Frame: 20 months

Five additional incisions will be taken and marked on the mastectomy specimens (A2-E2), positioned in radial direction and opposite to the biopsy points A-E. The distance will be measured by the pathologist in mm.

Outcome measurements will be the distribution of distances within the points A2-E2 (Friedman-Test), the correlation between distance points A2-E2 and corresponding biopsy points A to E as well as the correlation of the distance with RBT and with patient- and therapy-related factors (linear regression).
20 months
Detection of residual disease
Time Frame: 20 months

Each biopsy specimen will be histopathologically assessed for the presence of residual disease:

In case of SSM 10 biopsy specimens (points A-K) and in case of NSM 14 biopsy specimens (points A-O).

The measurement of this outcome will be carried out in a descriptive way of the percentage of biopsies with residual disease, because a low number of residual disease-positive biopsies will be expected.
20 months
Correlation of patient- and therapy-related factors with residual breast tissue (RBT) and with distance between surface of removed breast and glandular tissue
Time Frame: 20 months
Comparisons of patient- and therapy-related variables between SSM and NSM will be done with χ2 - and Student's t-tests for equal or unequal variances, wherever applicable. Forward-and backward logistic regression will be used to assess the influence of putative risk factors on RBT (binary dependent variable; 0: no RBT; 1: at least one probe with positive breast tissue detection). Variables will be included at P < 0.05 and excluded at P > 0.1. For all tests, statistical significance will be assumed at P ≤ 0.05.
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brust-Zentrum AG

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.

General Publications

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 (Actual)

April 12, 2016

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

August 4, 2017

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-01191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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