MarginProbe Qualitative Sub-Study
Research type
Research Study
Full title
MarginProbe (Does intra-operative Marginprobe use reduce re-excision rates?) Qualitative Sub-Study
IRAS ID
248089
Contact name
Nigel Bundred
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
0 years, 10 months, 10 days
Research summary
This will be a Sub-Study for the MarginProbe Trial; a trial addressing whether a new CE-marked technology, MarginProbe, used to assess completeness of excision during surgical therapeutic excision of breast cancers, can reduce the number of patients having to undergo re-excision surgery and therefore reduce the number of NHS repeat surgical operations in this group of patients.
We aim to use participants in this sub-study from several of the participating sites that run the main MarginProbe trial. We hope for the study to begin in February 2020 and will be open for 11/12 months.
The Qualitative Sub-Study will investigate the "lived" experience of women and surgeons participating in the MarginProbe Trial. Researchers from the University of Manchester will interview up to 30 women recruited onto the MarginProbe Trial, and up to 15 surgeons trained on, and delegated to, device use as part of the Trial. The aims of the study include:
i) to identify any differences in the "lived" experience of the women between the two study arms (control and device arm), and also between women with or without re-excision procedures.
ii) to acquire qualitative accounts of device use from surgeons participating in the MarginProbe study.REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0121
Date of REC Opinion
16 Mar 2020
REC opinion
Favourable Opinion