A Study of the Role of Sentinel Node Biopsy during Completion Mastectomy for Ductal Carcinoma in Situ.
Background:
The prevalence of lymph node metastasis in localized Ductal Carcinoma in Situ (DCIS) is quite low, hence patients undergoing breast conserving surgery (BCS) for DCIS do not have staging axillary procedure (Sentinel lymph node biopsy SLNB). However, guidelines recommend SLNB for patients having mastectomy as an initial procedure for DCIS. A subset of patients proceed to have a completion mastectomy after BCS for a DCIS due to close/ involved margins, with no guidance on whether to stage the axilla (SLNB) with it. The risks of invasive cancer in completion mastectomy specimen or axillary lymph node metastasis are considered to be very low. We hypothesize that majority of patients undergoing completion mastectomy for DCIS will not have an invasive cancer and therefore the risks of SLNB like limb oedema and sensory loss outweigh the benefits. Moreover,the risk factors associated with invasive cancer in the completion mastectomy specimen could be identified, and this will depend on the sample size and its incidence.
Objectives:
In patients who undergo completion mastectomy following breast conserving surgery for screen detected DCIS, look for:
- the incidence of invasive carcinoma following completion mastectomy
- the incidence of sentinel node metastases during completion mastectomy
- risk factors associated with invasive cancer in the completion mastectomy specimen
Recruitment info:
We’re looking for collaborators!
This study is exploring the need for routine sentinel node biopsy (SNB) during completion mastectomy for pure DCIS. The study group includes patients who have had breast conservation surgery for pure DCIS and subsequently have completion mastectomy due to involved/close margins. There is no guidance on the need for SNB in this group of patients. We hypothesise that most patients undergoing completion mastectomy for DCIS will not have an invasive cancer which raises the question of the need for routine sentinel lymph node biopsy as risks of SNB outweigh the benefits.
Please read through the study proposal which explains the aims and purpose of this study.
What will your role be?
· As a trainee collaborator you will collect data for at least 10 cases as part of the North-West Breast Research Collaborative.
· If you are interested in taking part in the study you will need to
- Email commands.study@gmail.com to get access to Research Electronic Data Capture (REDCap) which you will use to enter patient data.
- Register the study locally as a quality improvement project (formal ethical approval is not required, as determined by the Health Research Authority).
- Identify a consultant locally to act as a local supervisor and be named on the local audit department paperwork.
- Liaise with the unit MDT coordinator / audit department (and use our data collection guidance in the study proposal) to help identify suitable patients
Authorship and recognition:
Entry of 10 patients onto the REDCap database will ensure you get listed as a collaborative author on any subsequent publications
Please enquire via this email address commands.study@gmail.com if you want to be a collaborator or have any questions or queries.
Study Leads
Mirza Baig
Rajaram Burrah
Steering Committee
Hiba Fatayer
Talal Majeed
Emma Blower
Urvashi Singh
Shaneel Shah
Prof Cliona Kirwan
Contact
nwresearch.org 