SurgerySKININCT03470909
SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy
A study testing Skin-Sparing Mastectomy (SSM) and Nipple-Sparing Mastectomy (NSM) in people with Surgery, run by Brust-Zentrum AG at 1 site in Switzerland.
Trial summary
Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgery
- What is being tested?
- Skin-Sparing Mastectomy (SSM) and Nipple-Sparing Mastectomy (NSM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Apr 2016to 4 Aug 2017
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Skin-Sparing Mastectomy (SSM), Nipple-Sparing Mastectomy (NSM)
- Keywords
- Remaining breast tissue, Skin-Sparing Mastectomy, Nipple-Sparing Mastectomy, Prophylactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-Sparing Mastectomy (SSM)Procedure or surgery
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.
Nipple-Sparing Mastectomy (NSM)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin-Sparing Mastectomy (SSM) | Other | Not described Receives: Procedure: Skin-Sparing Mastectomy (SSM) |
| Nipple-Sparing Mastectomy (NSM) | Other | Not described Receives: Procedure: Nipple-Sparing Mastectomy (NSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 months
Secondary outcomes (3)
Distance between surface of the removed breast and glandular tissue
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).
Measured: 20 months
Detection of residual disease
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.
Measured: 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
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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start12 Apr 2016
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
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 SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brust-Zentrum AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470909
- Sponsor's protocol ID
- 2016-01191
- Other IDs
- 2016
- Acronym
- SKINI
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30830538
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SKINI - Prospective Evaluation of the Radicality of Breast Tissue Removal With Skin-Sparing and Nipple-Sparing Mastectomy (SSM or NSM)
- ClinicalTrials.gov ID
- NCT03470909
- Acronym / sponsor ID
- SKINI / 2016-01191
- Conditions
- Surgery
- Keywords
- Remaining breast tissue, Skin-Sparing Mastectomy, Nipple-Sparing Mastectomy, Prophylactic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Brust-Zentrum AGUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 20 Mar 2018 (actual)
- 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.
Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin-Sparing Mastectomy (SSM) | Other | Procedure: Skin-Sparing Mastectomy (SSM) |
| Nipple-Sparing Mastectomy (NSM) | Other | Procedure: Nipple-Sparing Mastectomy (NSM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not fulfilling inclusion criteria
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 |
|---|---|---|
| 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. | Procedure or surgery | Skin-Sparing Mastectomy (SSM) |
| 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. | Procedure or surgery | Nipple-Sparing Mastectomy (NSM) |
Primary outcome
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.
3 secondary outcomes
Distance between surface of the removed breast and glandular tissue
Time frame: 20 months
Detection of residual disease
Time frame: 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
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 21 Mar 2018.
- Derived from this study: PubMed 30830538Papassotiropoulos 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-Sparing Mastectomy (SSM) and Nipple-Sparing Mastectomy (NSM) in people with Surgery, run by Brust-Zentrum AG at 1 site in Switzerland.
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 3 inclusion and 1 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 21 Mar 2018. 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 Switzerland. 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?
Detection of residual breast tissue (RBT) (time frame: 20 months). 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 NCT03470909, 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 21 Mar 2018.