P16/Ki67 analysis to reduce the number of colposcopy referrals in CSP.
Research type
Research Study
Full title
A novel algorithm for cervical cancer screening may reduce the number of women referred for colposcopy unnecessarily, resulting in beneficial financial consequences and improved patient outcome.
IRAS ID
155727
Contact name
Gary Robinson
Contact email
Sponsor organisation
Royal Sussex County Hospital
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
The aim of this study is to demonstrate the possibility of significantly reducing the number of women referred unnecessarily for investigation (colposcopy) and treatment (large loop excision of the transformation zone (LLETZ)) after a routine cervical smear test. A simple, cost effective, non-invasive test that better identifies women likely to develop cervical cancer than the current algorithm, may prevent a large number of women from undergoing unnecessary, sometimes painful, physically traumatic procedures.
Currently, smears with low grade abnormalities, are tested for Human Papillomavirus (HPV). HPV positive patients are referred for colposcopy, HPV negative are returned to normal recall. It is widely accepted that women with high grade abnormalities are more likely to develop cervical cancer than those with low grade, and therefore will benefit from treatment (LLETZ). HPV subtypes 16 and 18 are known to be associated with cervical cancer and high grade abnormalities, however validated research regarding other subtypes and their relationship with disease progression is relatively limited.
The Roche Diagnostics CINtec Plus kit detects tumour markers P16 and Ki67 in cervical cytology preparations. It is designed to identify women with cervical abnormalities that have the potential to progress to cancer. In this study, 400 randomly selected samples that have tested positive for HPV subtypes other than 16 and 18, will be analysed for P16 and Ki67. Their colposcopy/LLETZ results will be reviewed and compared to the CINtec results. Correlations between high grade findings from colposcopy/LLETZ results and CINtec results will be identified and statistically analysed..
The study is being funded by the National School of Healthcare Science using this researcher’s training budget. Slide staining will take place at Roche Diagnostics (Burgess Hill). Primary slide preparation, HPV testing and staining analysis will take place at the Royal Sussex County Hospital (Brighton).REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1311
Date of REC Opinion
15 Jan 2015
REC opinion
Further Information Favourable Opinion