RNAscope Pan-UK OPSCC Testing
Research type
Research Study
Full title
The United Kingdom Validation Study of RNAscope (HPV Diagnostic Platform) in Oropharyngeal SCC
IRAS ID
204016
Contact name
Andrew G Schache
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 5 months, 24 days
Research summary
The last 3 decades have seen a rapid increase in the incidence of cancers arising from the tonsils and base of tongue (oropharyngeal SCC). The UK HPV Prevalence Study has recently demonstrated that the Human papillomavirus (HPV) is causative for the majority of these cancers. The best test (or diagnostic platform) to determine whether the tumours are HPV-positive (i.e. caused by the virus) or HPV-negative is a source for considerable debate with significant and ongoing implications for current clinical practice.
The recently published National Institute for Head & Care Excellence (NICE) guidelines for upper aerodigestive tract malignancy (NG36, Feb 2016) recognise the immediate necessity for improvements in HPV diagnostics platforms with a stated recommendation for further research into “…the comparative effectiveness of single-step laboratory diagnostic tests to identify HPV against current diagnostic test algorithms and standards…”.
This research seeks to provide validation of such a diagnostic platform (or diagnostic testing regime) using the resources remaining after completion of the UK HPV Prevalence study - one of the largest resources of its kind, a sample set .
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1726
Date of REC Opinion
14 Sep 2016
REC opinion
Favourable Opinion