Condition category
Cancer
Date applied
20/02/2017
Date assigned
27/03/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Miss Donna Watterson

ORCID ID

Contact details

University Hospital of South Manchester NHS Foundation Trust
The Nightingale Centre and Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 161 291 4045
donna.watterson@uhsm.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19495

Study information

Scientific title

Does intra­operative use of the MarginProbe device reduce the need for further re­-excision procedures after conservation surgery for breast cancer?

Acronym

Study hypothesis

Study aims:
1. To determine if intraoperative margin assessment after excision of a cancer reduces second operations (re-excision or mastectomy), compared to standard surgical practice by 9 months after primary surgery
2. To determine if the use of the MarginProbe device, after surgical tumour excision and tissue specimen radiography of a breast cancer, reduces rates of further surgical re-excision operations (re-excision or mastectomy), when compared to control/standard practice (whereby the wound is closed after radiography showing clear margins)

Ethics approval

North West/Greater Manchester West REC, 05/06/2015, ref: 15/NW/0306

Study design

Randomised; Interventional; Design type: Prevention, Device, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

All surgeons will perform standard wide local excision (BCS) using localisation of the lesion for impalpable lesions where required. Randomization will take place immediately after the main ex-vivo lumpectomy specimen has been excised, oriented, border marked, inspected, palpated and additional cavity shavings (per visual inspection, palpation and radiology) performed. Patients will be randomised in theatre, by call to the MAHSC CTU, to either standard procedure alone or standard procedure with the use of the MarginProbe device:

Device Arm: Measurements shall be taken with the MarginProbe on the outer final surface of each margin. Once the device has been applied to outer final surface of all margins, all margins with one or more positive readings on it should be shaved from the cavity. The procedure will then be concluded in the routine practice.

Control Arm: The procedure will be concluded in the routine practice.

MarginProbe use starts and ends during the primary lumpectomy procedure. Thus, patient management differs between the two study arms only during the procedure. Following the procedure, pathological assessment and any other patient management aspects are identical for both study arms. The follow-up period for both study arms is 9 months. Follow up visits (month 1, 6 and 9): FACT B +4, HADS and EQ5D Questionnaires and Patient Diary Cards Administered. Photographs for cosmesis completed at baseline and 9 months.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Reduction rates in re-excision procedures are determined by review of pathology reports for all participants to record subsequent surgeries at 9 months post initial surgery
2. Total number of re-excision procedures is determined by review of patient notes, clinical data and pathology reports at 9 months post initial surgery
3. Excision margins determined by review of pathology reports at 9 months post initial surgery

Secondary outcome measures

1. Quality of life measured by using validated self-completion disease specific and generic instruments, FACT-B, HADS, health-related utility (EQ5D) and the body image scale of SABIS administered at baseline (pre-surgery) and postal follow-up at 1, 3 and 9 months post-surgery
2. Cosmetic outcome assessment will be performed by two objective evaluators blinded to arm assignment based on pictures taken under standardized photographic conditions. The scoring will be performed using the validated 4-point Harvard scale. Pictures will be taken at baseline and 9 months post-surgery.
3. Impact of margin assessment on patients and carers will be measured by questionnaires assessing experiences and satisfaction and semi structured interviews exploring concerns, expectations, preferences, satisfaction and awareness of procedural differences. This will be a qualitative sub study of the main trial and timescales are dependent on when this is set up.
4. Clinical and cost effectiveness measured by review of hospital in-patient records and patient diary cards at 1, 3 and 9 months

Overall trial start date

24/03/2014

Overall trial end date

30/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically
2. Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b). Invasive lobular carcinoma does not require concomitant DCIS.
3. Tumour size 1.5cm - 4cm and undergoing BCS
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 460; UK Sample Size: 460

Participant exclusion criteria

1. Unsuitable for BCS on basis of tumour size (>4cm) or stage.
2. Radiotherapy contraindicated.
3. No histopathological evidence of DCIS or invasive lobular cancer.
4. Small invasive cancers (<1.5cm)
5. Multicentric Disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
6. Bilateral disease (diagnosed cancer in both breasts)
7. Neoadjuvant systemic therapy
8. Previous radiation in the operated breast
9. Implants in the operated breast
10. Pregnancy
11. Lactation
12. Cryo-assisted localisation
13. Patients who are undergoing full cavity excision following removal of the main lumpectomy specimen during initial lumpectomy procedure.

Recruitment start date

22/03/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
University Hospital of South Manchester NHS Foundation Trust The Nightingale Centre and Genesis Prevention Centre Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

St James's University Hospital
Leeds Teaching Hospitals NHS Trust Bexley Wing, Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Royal Derby Hospital
Derby Teaching Hospitals NHS Foundation Trust Lymphoedema and Palliative Medicine M&G Level 3 Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust NIHR CRN Eastern Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Western General Hospital
NHS Lothian Edinburgh Breast Unit
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Cancer Resource Centre Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

The Royal Bournemouth and Christchurch Hospitals
Castle Ln E
Bournemouth
BH7 7DW
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester

Sponsor details

Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 161 291 4045
sian.hannison@manchester.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal with intention to publish the findings from the trial approximately 1 year after trial closure.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from nigel.bundred@manchester.ac.uk

Intention to publish date

30/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates. 10/04/2017: Link to Cancer Help UK lay summary added to plain English Summary field