NCT03470909

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Apr 2016

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

April 12, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

March 5, 2018

Last Update Submit

March 20, 2018

Conditions

Surgery

Keywords

Remaining breast tissueSkin-Sparing MastectomyNipple-Sparing MastectomyProphylactic

Outcome Measures

Primary Outcomes (1)

  • Detection of residual breast tissue (RBT)

    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 Outcomes (3)

  • Distance between surface of the removed breast and glandular tissue

    20 months

  • Detection of residual disease

    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

    20 months

Study Arms (2)

Skin-Sparing Mastectomy (SSM)

OTHER
Procedure: Skin-Sparing Mastectomy (SSM)

Nipple-Sparing Mastectomy (NSM)

OTHER
Procedure: Nipple-Sparing Mastectomy (NSM)

Interventions

Skin-Sparing Mastectomy (SSM)PROCEDURE

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.

Skin-Sparing Mastectomy (SSM)
Nipple-Sparing Mastectomy (NSM)PROCEDURE

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.

Nipple-Sparing Mastectomy (NSM)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brust-Zentrum AG

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Papassotiropoulos B, Guth U, Chiesa F, Rageth C, Amann E, Baege A, Elfgen C, Varga Z, Moskovszky L, Endhardt K, Masser R, Tinguely M, Farhadi J, Lardi A, Dammann F, Diebold J, Li Q, Dubsky P, Tausch C. Prospective Evaluation of Residual Breast Tissue After Skin- or Nipple-Sparing Mastectomy: Results of the SKINI-Trial. Ann Surg Oncol. 2019 May;26(5):1254-1262. doi: 10.1245/s10434-019-07259-1. Epub 2019 Mar 4.

    PMID: 30830538DERIVED

MeSH Terms

Interventions

Mastectomy, Subcutaneous

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 20, 2018

Study Start

April 12, 2016

Primary Completion

August 4, 2017

Study Completion

August 4, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)