Condition category
Surgery
Date applied
11/11/2019
Date assigned
21/11/2019
Last edited
18/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Breast cancer affects many women across the globe each year. If the cancer is detected at an early stage most of the patients can be treated with breast-conserving surgery. This means that the surgeon then aims to remove only the tumor-bearing part of the breast as opposed to the whole breast. Patients treated with radiotherapy after initial breast-conserving surgery have been shown to have similar survival rates to patients where the whole breast is taken away. As improved surgical techniques have evolved, more patients can be operated on using breast-conserving surgery. After breast-conserving surgery there is a risk that the cancer-affected area is not be completely removed and the patient might need to undergo surgery again. This study aims to identify those patients at increased risk of needing a second operation due to incomplete removal of breast cancer after their first breast-conserving operation. If there are risk factors identifiable before the first surgical procedure, doctors could select the right patients for breast-conserving surgery in the future and identify patients at risk of having incomplete operations. This would also be helpful for the surgeon to know when to remove a larger part of the breast during the operation.

Who can participate?
All female patients operated with breast-conserving surgery for pre-stages of breast cancer or breast cancer at Skåne University Hospital in Malmö, Sweden, during the years 2015-2016 will be included as study patients. For comparison, patients from Skåne University Hospital and Kristianstad Central Hospital in 2017 will be included.

What does the study involve?
This study will only examine the patients' medical records from the surgical, pathology, operational and mammography departments. Patient and tumor characteristics such as age, height, weight, breast size and tumor size, location and type will be recorded. Patients in need of second surgery will then be compared to patients with complete first operations in order to identify patient and tumor characteristics associated with incomplete removal of the tumor. All data will be compiled with no identifying information and no new information about the patients will be gathered.

What are the possible benefits and risks of participating?
There are no direct physical risks to the participants because the study uses only their medical records. The risks of participating in our study is mainly the potential intrusion on privacy from having data extracted from personal medical records. This intrusion is limited by the ethic committee’s decision to only allow access to the medical records from the surgical clinic and from the time of the events and by defining which data can be collected. The study aims is that all women affected by breast cancer in the future will be benefited by the knowledge gained on risk factors for having to have a second operation and the possibility of more patients being successfully treated with breast-conserving surgery and a single surgery.

Where is the study run from?
Lund University (Sweden)

When is the study starting and how long is it expected to run for?
January 2017 to December 2017

Who is funding the study?
Lund University (Sweden) and Region Skåne (Sweden)

Who is the main contact?
Dr Julia Ellbrant, Julia.Ellbrant@med.lu.se

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Julia Ellbrant

ORCID ID

http://orcid.org/0000-0002-3241-1109

Contact details

Kirurgiska kliniken
Jan Waldenströmsg. 11A
SUS
Malmö
205 02
Sweden
+46 (0)40-331772
juila.ellbrant@med.lu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Pre-operative patient and tumor characteristics associated with increased risk of non-radical margins after breast-conserving surgery

Acronym

Study hypothesis

Preoperative patient and tumor characteristics can be associated with non-radical margins after breast-conserving surgery and therefore be pre-operatively identified.

Ethics approval

Approved 01/01/2018, Regional Ethical Review Board in Lund, Sweden Etikprövningsnämden i Lund (Box 133, 22100, Lund, Sweden; +46 (0)104750800; registrator@etikprovning.se), Ref: Dnr 2018/622

Study design

Observational retrospective cross-sectional record review. Multicenter design with internal and external validation cohorts

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Breast cancer patients operated on using breast-conserving surgery

Intervention

All female patients operated with breast-conserving surgery for pre-stages of breast cancer or with breast cancer at Skåne University Hospital in Malmö, Sweden during the years 2015-2016 will be included as study patients. For comparison, patients from Malmö and Kristianstad Central Hospital, Sweden, in 2017 will be included as a validation population. The patients’ medical records from the surgical, pathology, operational and mammography departments are collected extracting pre-defined factors. Patient and tumor characteristics such as age, height, weight, breast size and tumor size, location and type will be recorded. Patients will be analysed divided into two groups, radical and not radical at first surgery. Patients in need of second surgery will then be compared to patients with complete first operations in search of patient and tumor characteristics associated with incomplete removal of the tumor. All data will be compiled de-identified and no new information about the patients are gathered other than existing information already known by the patients.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

All measured retrospectively and extracted from medical records:
1. Number of patients with non-radical breast conserving surgery after first procedure
2. Preoperative tumor and patient characteristics such as age, BMI, breast side and size, screening detection, palpability of tumor, location in breast, distance from mamilla, lymph node palpability and status, previous breast operations, radiographic characteristics and size, biopsy results

Secondary outcome measures

All measured retrospectively and extracted from medical records:
Post-operative tumor and patient characteristics such as method of operation, indication method, pathology results from tumor and axilla, weight of excised lump and operation time

Overall trial start date

01/01/2017

Overall trial end date

30/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Female patients operated with breast-conserving surgery with a final diagnosis of in situ or invasive cancer at Skåne University Hospital 2015-2016 for study cohort or 2017 for validation cohort or at Kristianstad hospital in 2017 for external validation

Participant type

Patient

Age group

All

Gender

Female

Target number of participants

779

Participant exclusion criteria

1. Male gender
2. Primary operation not coded as breast-conserving surgery
3. Neoadjuvant treatment
4. Benign final pathology result

Recruitment start date

01/01/2015

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Skåne University Hospital, Surgical clinic
Jan Waldenströmsgata 11 A
Malmö
205 02
Sweden

Trial participating centre

Kristianstad Hospital, Surgical clinic
Jan Hedlundsväg 5
Kristianstad
291 33
Sweden

Sponsor information

Organisation

Lund University

Sponsor details

Box 117
Lund
221 00
Sweden
+46 (0)46 222 00 00
lu@lu.se

Sponsor type

University/education

Website

www.lu.se

Funders

Funder type

University/education

Funder name

Lunds Universitet

Alternative name(s)

Lund University

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Region Skåne

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication planned as original article in a peer-reviewed journal in 2020.

IPD sharing statement:
The exact data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/11/2019: Trial's existence confirmed by Regionala Etikprövningsnämnden i Lund [Lund Regional Ethics Review Board].