ACES Primary Care
Research type
Research Study
Full title
Alternative CErvical Screening in Primary Care.
IRAS ID
309113
Contact name
Emma J Crosbie
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Research Summary:
What was the study 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 and where?
We recruited 1517 people who were attending routine cervical screening at their GP practice.The study was funding by NIHR, sponsored by The University of Manchester and recruitment was conducted by staff at GP practices and hospitals across Manchester. These include Bowland Medical Practice, The Maples Medical Centre, The Lakes Medical Practice, Surrey Lodge Group Practice, Hawthorn Medical Centre, Urban Village Medical Practice, Didsbury Medical Centre and Lancaster Queen Square Medical Practice and Manchester University NHS Foundation trust.
How did we do it?
We collected urine samples from people in clinic, before their cervical screening test. Urine was collected 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 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 looked at the accuracy of the urine HPV result against the HPV result from the routine cervical screening test for each person. We looked at how accurate both were 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.
What did we find?
When tested for HPV, the urine collected using a colli-pee was 85% effective at identifying people without cervical disease.The routine cervical test was 87% effective at identifying people without cervical disease.
When tested for HPV, the urine collected using a colli-pee identified 24 out of 25 (96%) people with high grade cervical pre-cancer.
The routine cervical test identified 100% of people with high grade pre-cervical cancer.
The questionnaire showed that people liked urine self-sampling but some prefer traditional screening, making choice an important consideration when making decisions about future cervical screening programmes.
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 who are at greater risk of cervical cancer (people with a history of smoking and people who do not attend cervical screening). We are also looking at how the urine sample can be collected at home.Where can I read more?
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F40953936%252F%2FNBTI%2FhzvEAQ%2FAQ%2Fd116fab5-d94f-4c2c-a599-a08812ee9056%2F2%2FwIHGvMB52R&data=05%7C02%7Ccornwallandplymouth.rec%40hra.nhs.uk%7Cf17c200f316c48dc621608de89b1ec7b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639099594429543832%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Gc%2F4Bp5Vw1vbhY8hEEkxawkRpR4kjhAcXQNE%2BklUuE0%3D&reserved=0Cervical 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 1500-2000 women attending routine cervical screening in primary care across Greater Manchester. Samples will be tested for high risk HPV. HPV positive samples may also 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
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
22/SW/0007
Date of REC Opinion
14 Feb 2022
REC opinion
Further Information Favourable Opinion