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.
Results Summary
What were we trying to do?
Cervical screening is a test to help prevent cervical cancer and can save lives. However, only 7 in 10 people attend their screening appointment. This can be for a number of reasons such as embarrassment, inconvenience, pain or fear. Our goal is to find ways of making cervical screening easy, accurate and convenient so that everyone can attend. We think a urine test could help break down barriers and encourage more people to take part in cervical screening.
Who took part?
We recruited 480 people who had been referred for a colposcopy appointment to investigate a positive cervical screening (smear test) result.
The study was funding by NIHR, sponsored by The University of Manchester and recruitment was conducted by staff at Manchester University NHS Foundation Trust (St Mary’s Hospital, Manchester).
How did we do it?
We collected urine and cervical samples from people in clinic, before their colposcopy procedure. We wanted to see if there are better ways to collect urine from people so half the people in the study collected urine in a small pot, and half the people collected urine using a device called a ‘Colli-pee’. The colli-pee is designed to collect the first bit of urine after you start to wee. It collects a specified amount of urine and a special liquid in the collection tube helps to preserve the sample.
We asked people to fill out a questionnaire to see how they felt about self-collecting urine, and what they wanted for the future of cervical screening. People then continued to have their normal NHS care.
We tested urine and cervical samples for a virus called Human papillomavirus (HPV). Nearly all cervical cancers are caused by persistent infection with certain types of HPV. HPV testing is performed on all cervical samples collected for current routine NHS cervical screening.
We then looked at the accuracy of testing a urine sample for HPV for the identification of people with high grade cervical pre-cancer. High grade cervical pre-cancer means people who have a higher chance of developing cervical cancer. We also looked at the difference between each method of urine collection.What did we find?
We found that, for the HPV test, the colli-pee was a better way to collect urine.
When tested for HPV, the urine collected using a colli-pee identified 112 out of 124 (90.3%) people with high grade cervical pre-cancer.
When tested for HPV, the urine collected in a small pot identified 91 out of 124 (73.4%) people with high grade pre-cervical cancer.
For comparison, routine cervical screening (also known as the smear test) picks up 95 out of every 100 cervical pre-cancers (95%).
The questionnaire showed that people felt confident collecting a urine sample.
What are we doing now?
HPV testing using colli-pee collected urine shows promise as an alternative test for cervical screening. We are now performing more studies to advance urine testing. This includes urine testing in people attending routine cervical screening and people who are at greater risk of cervical cancer (people with a history of smoking and people who do not attend screening).
Where can I read more?
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F38660737%252F%2FNBTI%2FpTvEAQ%2FAQ%2Fbd678646-3fd7-44b7-9904-2364437974f0%2F2%2Fnlb5o4OyIO&data=05%7C02%7Cgmwest.rec%40hra.nhs.uk%7C4a91ec9c146a423fff1708de89b617dc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639099612387663177%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=3dbKue8wZFhot5HCZPXApHPjEOM2ux7BXEWftPCYMAA%3D&reserved=0REC 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