CompletedNot ApplicableInterventional

Comparing self-taken samples from the vagina and urine with samples taken by a doctor or nurse in women between 25-65 years who test positive for HPV

This study looks at new ways for women aged 25-65 to get tested for HPV, the virus linked to cervical cancer. Currently, some women miss their regular cervical screening appointments. This research compares samples women take themselves, specifically from the vagina using swabs and from urine, with the standard samples taken by a doctor or nurse. The goal is to see if self-sampling is just as good at finding HPV. If successful, this could offer a simpler way for women to get screened at home, potentially making it easier for more women to take part and helping to prevent cervical cancer.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Queen Mary University of London

Enrolment target

216

Start

01 May 2024

Estimated completion

21 Oct 2024

HPV screening for cervical cancer

What is this study about?

You might have heard about cervical screening, sometimes called a 'smear test'. This test helps find changes in the cervix that could lead to cancer. At the moment, the main focus of this screening is to look for a virus called HPV (Human Papillomavirus), because certain types of HPV can cause cervical cancer. The current test usually involves a doctor or nurse taking a sample from your cervix.

This study is exploring a new idea: what if women could take their own samples at home? This is called 'self-sampling'. We want to see if samples women take themselves, either from the vagina using a special swab or from urine, are as good at finding HPV as the samples taken by a healthcare professional. We already know that finding HPV is more accurate than the older method of looking at cells under a microscope.

The main aim is to make cervical screening easier and more accessible. Many women don't attend their screening appointments for various reasons. Offering a simple home test could be a game-changer. It might help more women take part in screening, potentially reducing cases of cervical cancer by finding cell changes earlier, before they become a problem.

Key takeaways

Exploring easier ways to test for HPV, which causes cervical cancer.
Comparing self-taken samples (urine, vaginal swab) with doctor-taken samples.
Aims to make cervical screening more accessible and increase participation.
You'll still receive your usual doctor-taken cervical screening.
All samples collected are safe for research.
Funded by Cancer Research UK.

Who may be eligible?

This study is looking for women between the ages of 25 and 65 years old. To join, you must already be part of the national cervical screening programme.

However, there are some reasons why you wouldn't be able to take part. If you're pregnant, or if you've had surgery that means you no longer have a cervix, this study isn't for you. Also, if you've had treatment for abnormal cervical cells (called CIN) in the last three years, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 25 and 65 years old?
Are you eligible for the routine NHS cervical screening programme?
Are you currently pregnant? (If yes, you cannot join).
Do you have a cervix? (If no, you cannot join).
Have you had treatment for abnormal cervical cells (CIN) in the last 3 years? (If yes, you cannot join).

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to provide some samples. You'll receive special kits to collect a urine sample and two vaginal self-samples using swabs. For the vaginal samples, one swab will be placed into a special liquid (called a 'wet' swab) and the other will be stored dry. You'll also be asked to provide a second urine sample, ideally the next day, and send all these samples back to the lab by post. These samples will be stored and tested. Crucially, you will still have your usual cervical sample taken by a doctor or nurse during your regular screening appointment, and this will determine any further medical care you might need.

Potential risks and benefits

A potential benefit of participating is helping to improve cervical screening for all women in the future, by making it easier and more convenient. This could lead to more women getting screened and finding pre-cancerous changes earlier. All types of self-sampling and clinician-taken samples used in this study are considered safe and are already routinely used or are safe for research. Your clinical care will not be affected by taking part as your standard doctor-taken sample will guide any treatment. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal London Hospital, Barts Health
City only
London, United Kingdom

Common questions

What is HPV?

HPV stands for Human Papillomavirus. It's a common virus, and some types can cause changes in the body that might lead to certain cancers, including cervical cancer.

What is cervical screening?

Cervical screening, sometimes called a smear test, is a health check that looks for high-risk types of HPV and any changes to the cells in your cervix. It helps prevent cervical cancer.

Will my regular screening still happen?

Yes, you will still have your standard cervical screening sample taken by a doctor or nurse, and any further care you need will be based on those results.

Is it safe to collect samples myself?

Yes, the self-sampling methods for urine and vaginal samples are considered safe for research purposes.

Who is paying for this study?

The study is being funded by Cancer Research UK.

How to find out more

Ranjit Manchanda

r.manchanda@qmul.ac.uk +44 (0)207 882 5555 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.