Ki67 in Breast Cancer
Research type
Research Study
Full title
Value of Ki67 in Breast Cancer
IRAS ID
241962
Contact name
Zenon Rayter
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
2 years, 8 months, 29 days
Research summary
The tumour proliferation rate or the mitotic activity of breast cancers helps to guide neoadjuvant and adjuvant treatment decisions by the multi-disciplinary team. The current method of counting of mitosis (grading to tumour) has been shown to be concordant between core biopsy and surgical excision in only 70% of cases, making neoadjuvant treatment decisions difficult.
Ki67 is a nuclear protein associated with cellular proliferation in all stages of cell growth rather than just the M-phase of cell growth which mitotic counting assesses. Immunostaining with the monoclonal antibody Ki67 enables the assessment of the growth fraction of neoplastic cell populations. Studies have demonstrated that the Ki67 positivity confers a higher risk of recurrence and a worse survival rate in patients with early breast cancer.
To date, Ki67 is not implemented in standard routine pathology for breast cancer due to the inconsistency in Ki67 assessment. No standard operating procedure or generally accepted cut-off definition for Ki67 exists. There is diffuse variability in the counting method used for assessment leading to differences in the Ki67-labelling Index produced between different laboratories.
This study will investigate whether a standardised, reproducible Ki67-labelling index score can be produced using automated digital analysis. Advanced digital image processing systems and compatible software have been introduced since 2010 to aid the high volume immunohistochemical (IHC) analysis and scoring. Following which we plan to view the concordance of Ki67 labeling index scores on core biopsy to surgical excision specimens. We hope to correlate the proliferation rate of breast cancer with the tumour grade to determine whether Ki67-labelling index scores can be categorized into 3 categories: low, intermediate and high to help more accurate grading of breast cancers on core biopsy and thereby improve the concordance rate for grade between initial biopsy and final excision. This will guide treatment decisions more accurately.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0348
Date of REC Opinion
21 Aug 2018
REC opinion
Favourable Opinion