Can TTL in conjunction with other factors reduce unnecessary clearance
Research type
Research Study
Full title
Can Total Tumour Load calculated by One Step Nucleic Acid Amplification be used in conjunction with Hormone Receptor status, Histological grade and pathological evidence of lymphovascular invasion to predict whether further lymph node metastasis will be present and therefore reduce unnecessary axillary cleatances?
IRAS ID
231029
Contact name
Julia Thompson
Contact email
Sponsor organisation
Buckinghamshire Healthcare NHS Trust
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Can Total Tumour Load calculated by One Step Nucleic Acid Amplification be used in conjunction with Hormone Receptor Status, Histological Grade and pathological evidence of lymphovascular invasion, to predict whether further lymph node metastasis will be present and therefore reduce unnecessary axiliary clearances?
Breast Cancer is the most common cancer in the UK (2013) with over 50,000 new cases each year and due to advances in detection and management, most are detected at an early stage. The guidelines for the diagnosis of breast cancer involve a triple approach; Clinical examination, radiological imaging and pathological investigations. From the pathological investigations information on the histological grade and hormone receptor status are determined and used to develop a treatment plan for the patient involving surgical removal of the tumour and post operative drug treatments. During surgical removal of the tumour the patient may have a sentinel lymph node biopsy as the involvement of the sentinel lymph node (SLN) is used to predict overall axillary lymph node states. In 2010 there was the introduction of molecular analysis using One Step Nucleic Acid Amplification (OSNA) which is a rapid molecular intraoperative diagnostic technique that allows the detection of lymph node metastasis by measuring the amplification of the epithelial CK19 and providing a semi quantitative result of the number of copies present in the sample. The current surgical practise when macrometastasis are present in axillary nodes is an area of debate. Historically all patients that had lymph nodes with macrometastasis would have a completion axillary lymph node dissection (cALND) to enable accurate staging and prevent disease recurrence. However complete removal of the axillary nodes is associated with lymphoedema, arm paresthesia, chronic pain and immobility in up to 50% of patients compared to up to 15% for sentinel node biopsy.Also in approximately half of patients’ (40-60%) no further positive nodes are identified. Therefore if other factors like hormone receptor status, lymphovascular invasion, total tumour load and tumour size and grade can be used to provide indications of sentinel lymph node metastasis then clinicians would be able to make informed decisions as to whether a patient is likely to require an axillary dissection.
At Wycombe General Hospital there has been 1797 patients that have received OSNA analysis since May 2010. A minimum of 376 patients with macro metastases two plus positive nodes would be identified on the RD100i software and the data backup system and then the report of each patient’s breast core biopsy will be reviewed on WinPath the Laboratory Information Management System (LIMS) to identify the hormone receptor status, histological grade and if lymphovascular invasion was present. If a biomarker had not been performed on the core biopsy then a further 3µm section may need to be cut and stained using the Dako Autostainer Link 48 and Dako ready to use antibodies in accordance with the laboratories standard operating procedures. The post operative report for each patient can then used to determine whether further lymph nodes were positive for metastases and identify how many more nodes were positive.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0355
Date of REC Opinion
22 May 2018
REC opinion
Favourable Opinion