Urine HPV testing for cervical screening
Research type
Research Study
Full title
Urine HPV testing for cervical screening
IRAS ID
286415
Contact name
Emma J Crosbie
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Cervical screening can save lives from cervical cancer, yet only 7 in 10 women in the UK attend screening, the lowest rate in 20 years. Reasons include embarrassment, fear of examination and inconvenience. Cervical screening is carried out by collecting cells from the cervix (neck of the womb) with a soft brush. These cells are tested for a virus known to cause cancer called human papillomavirus (HPV). If HPV is detected, the cells are examined under the microscope. If they look abnormal, the woman is referred to colposcopy clinic, where cells that are found to be ‘pre-cancerous’ (cells with potential to become cancer cells) are identified and treated. To increase screening rates, vaginal ‘self-sampling’ has been tried, where a woman collects cells from her vagina at home and returns the sample by post, however only 1 in 10 women return the sample. There is therefore an urgent need for new ways to reverse declining rates of cervical screening.
We have developed a urine test that can detect HPV. This test has the potential to remove many of the current barriers to screening and could substantially increase the number of women attending. This study will see if a urine test can accurately identify women with cervical pre-cancer by comparing HPV detection rates in urine and cervical samples. We will recruit around 400 women with abnormal cervical screening results attending gynaecology clinics at Manchester University NHS Foundation Trust. Samples will be tested for high risk HPV and HPV positive samples will undergo methylation testing. Women will be asked to complete a short questionnaire to understand views and preferences of current cervical screening attendees. This study will help establish whether the clinical performance of urine testing is sufficient to recommend its use as an NHS cervical screening test.
Funding is provided by NIHR.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0389
Date of REC Opinion
17 Nov 2020
REC opinion
Further Information Favourable Opinion