Ductal carcinoma In Situ Cavity shave (DISC) RCT Pilot Study
Research type
Research Study
Full title
Ductal carcinoma In Situ Cavity shave (DISC) Pilot Randomised Control Trial (RCT): A Feasibility Study
IRAS ID
345482
Contact name
Sarah SK Tang
Contact email
Sponsor organisation
St George's University of London
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Breast conservation surgery (BCS) contributes to 55% of breast cancer operations. In BCS, the cancer is removed in a lump of breast tissue (lumpectomy) and the rest of the breast is treated by radiotherapy. BCS has equal survival outcomes to mastectomy. When compared with mastectomy, BCS reduces post-operative risks, speeds up recovery and improves the psychological, physical and sexual wellbeing of patients. However if the cancer reaches the lumpectomy margin, patients need a second operation to remove more breast tissue. Needing a second operation causes anxiety, delays radiotherapy and worsens cosmetic outcome. The second operation is also less precise and there is a higher risk of cancer recurrence if the margins are not clear the first time.
Previous studies for invasive breast cancer have shown that routinely taking 4 additional shaves of breast tissue around the cancer (4 quadrant cavity shaving) during the first surgery can reduce cancerous cells being left behind and reduce the need for repeat surgery to get clear margins. However, these studies have not focussed on preinvasive breast cancer (DCIS) which has a much higher risk of needing a second operation (29%) compared to invasive cancer (14%). Previous studies have also not looked at patient experience, cosmetic outcome and cancer recurrence.
Our study will therefore look specifically at DCIS. We will compare standard surgery (no routine extra shaves) to surgery that includes routine 4 quadrant cavity shaving in patients having DCIS removed in a lumpectomy. We will look for differences in the number of second operations required, post-surgery cosmetic appearance, patient experience and future breast cancer recurrence.
This is a feasibility study involving a small number of patients in a single hospital to try out the study plan and to prepare for the smooth running of a larger national study with more hospitals and breast surgeons participating.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
25/SW/0044
Date of REC Opinion
2 Jun 2025
REC opinion
Further Information Favourable Opinion