Extended HPV genotyping in cervical screening
Research type
Research Study
Full title
Extended HPV genotyping in cervical screening to better stratify both prevalent and long-term risk of high-grade cervical disease
IRAS ID
217791
Contact name
Mary McMenamin
Contact email
Sponsor organisation
Research & Development, CTRIC, WHSCT
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Persistent infection with 1 of 14 high-risk genotypes of human papillomavirus (hrHPV) is a necessary, but not sufficient cause of cervical cancer. Among these it is widely accepted that HPV16 and HPV18 present the highest risk as these genotypes are associated with over 70% of all cervical cancers and that individual typing for these two oncogenic viruses is sufficient in cervical screening. However, emerging evidence has demonstrated that the risks of high-grade cervical disease and cancer associated with several of the other hrHPV genotypes, which are usually tested for as a pool, warrant further investigation as some of these genotypes present greater risks for high-grade disease and cancer than the risks associated with HPV18. Considering the fluidity of the information available regarding HPV genotype and risk, together with predicted changes in oncogenic potential of the other hrHPV types as HPV16 and HPV18 become less prevalent with vaccination, the requirement for extended genotyping is evident. \nSuch changes in cervical screening strategy could help to ensure that the optimum sample information is used to stratify risk of prevalent and long-term high-grade cervical disease to improve management strategies. We will perform a pilot study to determine the clinical utility of full hrHPV genotyping by next generation sequencing in HPV positive, archived and anonymised cervical cytology samples. The study is retrospective as clinical outcomes will have already been ascertained for participant samples before full genotyping of the same samples is performed. Sensitivity, specificity and positive predictive value of full genotyping for high-grade disease, as well as risk associated with specific genotypes will be determined.
REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0021
Date of REC Opinion
10 Mar 2017
REC opinion
Favourable Opinion