The Catch-up Screen project is being run in selected GP practices across Manchester and the Yorkshire and Humber regions. Eligible patients in these regions will be contacted by their GP practice and invited to take part. You cannot volunteer for this study.
Patients from participating GP practices may be invited to take part if they are aged between 60 and 79 and are no longer being invited for routine cervical screening as part of the NHS programme. Women cannot take part if they have had a hysterectomy which included the removal of their cervix.
Catch-up screen offers cervical screening to women in their 60s and 70s from a urine sample they can take themselves at home. The urine kit will be sent to selected women by post, with pre-paid return packaging included so that the urine sample can be posted directly to the laboratory for testing afterwards.
This additional “Catch-up Screen” is not normally offered by the NHS, so it provides an opportunity for an additional cervical screen without the need to visit a GP practice for a smear test. The project results will help the NHS to decide whether a catch-up urine test should be offered to all women in their 60s and 70s.
Cervical Screening and Human Papillomavirus (HPV)
Many women will have had smear tests in the past which involves a nurse or doctor collecting cells from the cervix (neck of the womb) with a soft brush. Since 2019, a new test has been introduced which detects a virus called human papillomavirus (HPV). This is better because nearly all cervical cancers are caused by HPV.
HPV is very common and most people will get the virus at some point in their life. In most cases, the immune system can get rid of the virus without them ever knowing they had it. But sometimes, HPV can cause cells in the cervix to become abnormal and in some cases the abnormal cells can go on to develop into cancer.
HPV is spread through close skin to skin contact during any type of sexual activity. It can stay in the body forever without causing any symptoms. This means that women of all ages, even if they are no longer sexually active, can still have an HPV infection.
Most women who are found to have HPV will not go on to develop cervical cancer because their HPV infection disappears without any problems. However, women whose HPV infection does not clear may be at higher risk of developing cancer in the future and can undergo further tests to reduce this risk.
What the study involves
The NHS offers cervical screening to women aged 25-64 years. Women who have an HPV test before they stop screening are at a very low risk of developing cervical cancer.
Women invited to take part in Catch-up Screen will be offered a catch-up HPV test which involves taking a urine sample by themselves at home. This new urine test has been shown to be as good as a traditional “smear” test taken by a nurse so there is no need to visit a GP surgery. The urine kit will be sent to selected women by post, with pre-paid return packaging included so that the urine sample can be posted directly to the laboratory for testing afterwards.
Selected women will receive a pre-invitation letter and information leaflet from their GP practice before their urine kit is sent to them by the post. GP practices will provide details of a local researcher to contact for further information and discussion about the project. Once the urine kit is sent out, the local researcher will either telephone or text invited women to again provide an opportunity to discuss the research and answer any questions women may have.
The results of the urine test will be posted to participating women within about 3 weeks and women who are found to have HPV will be invited to either have a repeat urine test after 6 months or see a gynaecologist or specially trained nurse for further tests.
How and when to take the urine sample
Ideally, the urine sample should be taken first thing in the morning before washing.
It is important not to urinate or bathe, shower or wash the genital area for at least 1 hour before taking the urine sample.
It is important that the urine sample is collected correctly so that the results are accurate. Invited women will receive a urine device called a “colli-pee” which allows them to collect the first part of their urine. The colli-pee device will allow the tube to be filled correctly and the excess urine will then flow into the toilet. It allows women to urinate without stopping the stream. The following video demonstrates how the colli-pee works:
It is important to read the instructions supplied with the urine kit carefully before taking the urine sample. If possible, women should post the urine sample back to the laboratory (using the FREEPOST returns box supplied) on the same day.
All data collected during the course of the research will be kept strictly confidential. Only the staff based at participating GP surgeries and hospitals will have access to personal information for the purpose of contacting patients about the project, communicating their results and for direct medical care.
By returning their urine sample and consent form, patients will consent for the London School of Hygiene & Tropical Medicine (LSHTM) study team to record the results of the urine test and any follow-up appointments, in addition to responses to questions asked over the telephone or given on feedback forms. None of this information will be linked to patient names or contact details. Instead, a project number will be used, which means that neither laboratory scientists handling the samples nor researchers analysing the research results will be able to identify study participants.
This consent does not cover other data collection during the study. The Health Research Authority, advised by the Confidentiality Advisory Group, have given their support to identify and collect data from all women who are invited to take part in the project. Anonymous information will be collected about all women, including those who do not return a urine sample. This is important for evaluating the success of the Catch-up Screen project. This will be done without contacting patients and without the research team being able to identify anyone. The following information from all those invited will be collected from GP notes: partial date of birth (month and year), postcode, ethnicity, dates and results of previous smear tests and details of any previous cervical abnormalities that may have been diagnosed in the past.
The LSHTM researchers will also continue to follow the health of everyone invited to participate in this research for the rest of their lives. The linkage will be done centrally by NHS England who hold and process cervical screening records, data on cancer registration (National Cancer Registration and Analysis Service) and the civil registration of deaths on behalf of the Office of National Statistics. Participating GP practices will securely send the NHS number and date of birth of those invited to NHS England for linkage to these data. NHS England will use NHS number and date of birth only for this purpose, and will remove all identifying information before returning the anonymous data to the LSHTM researchers for analysis.
At the end of the project, fully anonymised data may be made available to researchers at other institutions in accordance with the Data Protection Act 2018.
If patients do not want their anonymous information used in this way, they can opt out by contacting participating GP practices using the contact details provided in patient invitations and on GP practice posters. If patients from participating GP practices do not opt out, their anonymous information will be processed as described above.
All parties involved in this research will have a duty of confidentiality to patients as research participants and all data handling, processing, storage and destruction of their data will be done in accordance with General Data Protection Regulation (GDPR) and the Data Protection Act 2018. This includes the secure storage of any paper records and strict rules for the secure storage of electronic data. Invited patients can find out more about how their information is used on the HRA website or by contacting the Project Coordinating Centre at LSHTM (firstname.lastname@example.org).
The research project is sponsored by the London School of Hygiene & Tropical Medicine (LSHTM). Assistant Professor Clare Gilham and Professor Julian Peto from the LSHTM are leading this research in collaboration with Professor Emma Crosbie from the University of Manchester, Professor Una Macleod from the University of Hull and Dr Belinda Nedjai at Queen Mary University of London.
This project is funded by Yorkshire Cancer Research.
This research has been reviewed and approved by a Research Ethics Committee to protect your interests. It has also been reviewed by the Confidentiality Advisory Group, who provide advice concerning confidential patient data to the Health Research Authority.