Cervical screening by HPV testing followed by methods of triage
Research type
Research Study
Full title
Human papillomavirus (HPV) testing as a means of primary screening of cervical samples as part of the cervical screening programme, followed by three methods of triage to determine significant disease, compared against current methods of screening by cervical cytology.
IRAS ID
167441
Contact name
Jacqueline Jamison
Contact email
Sponsor organisation
NHSCT
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
The aim of this study is to look at different types of tests which can be used to identity precancerous changes of the cervix. In this study our focus will be to investigate different triage methods (triage = an additional test to determine management of women who have a positive primary test) for testing cervical cytology samples post primary human papillomavirus (HPV) testing and we will also compare two methods of HPV testing for the primary screening method. It is expected that HPV testing will be used as the method of primary screening in the NHS Cervical Screening Programme. Current estimates are that the NHS cervical screening programme will move over to primary HPV testing in approx. 2018. HPV testing may lead to a relatively inexpensive, automated, highly sensitive and highly specific primary screening method which will replace the more labour intensive, expensive and subjective method of cytology.
To be clear however, the focus of the study will be to investigate the potential role of 3 methods for the triage of HPV positive samples; these being cytology (the current primary screening method; this is the favoured model); a new commercial biomarker test; and a novel in-house molecular biomarker test.
This study will generate useful information to help laboratory staff understand the impact any change will have on the screening programme and offer data which can be used by frontline stakeholders to ask questions and prime additional research into this field.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0259
Date of REC Opinion
25 Mar 2015
REC opinion
Favourable Opinion