A study to understand more about high risk HPV

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Cervical cancer

Status:

Closed

This study aims to learn more about the human papilloma virus (HPV). It is for women between the ages of 25 and 55 who have had an abnormal smear test result. It is also recruiting younger women who have not started cervical screening.

The study is taking place in Oxford.

Cancer Research UK supports this study.

More about this trial

The human papilloma virus (HPV) is a major cause of the main types of cervical cancer. Some types of HPV are called ‘high risk’ because they are linked to cervical cancer.

Most sexually active women will have an HPV infection at some point in their lifetime. But for most, it does not cause any symptoms and the body’s immune system Open a glossary item

clears it. A small percentage of infections aren’t cleared. The HPV causes changes in the cells of the cervix Open a glossary item

and these changes may slowly develop into cancer over time.

Cervical screening Open a glossary item

aims to prevent cancer by finding and treating abnormal cell changes in the cervix. Treatment to remove or destroy these abnormal cells works well. But they can have unwanted side effects.

Researchers want to find new ways to treat abnormal cervical cells. But first, they need to understand more about the body’s defences. They want to find out how the body successfully clears HPV. And why it sometimes fails to do this. Researchers have looked at this in the past but the results are unclear.

The main aim of the study is to understand more about high risk HPV. In the future, these results could help to develop treatments that don’t involve surgery and have fewer side effects.

Please note – there is no direct benefit to you if you take part in this study. But it might improve treatment for women with abnormal cells in the cervix in the future.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join group 1 (cohort 1) if all of the following apply.

You:

are a woman aged between 16 to 24
are willing to give blood samples and vaginal swabs
are sexually active or have been in the past
are willing to abstain from sexual intercourse for 48 hours before taking the vaginal swabs

You may be able to join group 2 (cohort 2) if all of the following apply.
You:

are a woman, 25 to 55 years old
are willing to give blood samples and vaginal swabs
have had an abnormal cervical screening test result that showed borderline or mild cell changes (low grade dyskaryosis) and you have HPV or moderate to severe cell changes (high grade dyskaryosis)
have been referred to a colposcopy clinic for a closer look at your cervix
are willing to abstain from sexual intercourse for 48 hours before taking the vaginal swabs

Who can’t take part

You cannot join either group if any of these apply.
You:

have cervical cancer or your doctor suspects this
are having chemotherapy or radiotherapy or you had either in the last 6 months
are taking or have taken steroids in the last 3 months
have any other medical condition that means your doctor thinks you can’t join this study
have HIV or any other disease of the immune system
are pregnant or breastfeeding

Trial design

The researchers hope to find 400 women to join this study. The study visits take place at the Churchill Hospital in Oxford. The researchers are inviting:

250 women who are 16 to 24 years old to join group 1 (cohort 1) – this is for women who are sexually active or have been in the past
150 women who are 25 to 55 years old to join group 2 (cohort 2) - this is for women who had an abnormal screening test result and are having an examination of the cervix (a colposcopy)

The researchers will study these women over time. They track any HPV infections that develop and see how long they last. At the same time, they will measure the body’s immune response to find out how it clears the infection or why it sometimes doesn’t.

At the first visit the study team ask:

whether you had the HPV vaccine and if you had the full course
about your menstrual cycle
if you use contraceptives
if you smoke

They ask you to take 2 samples from the inside of your vagina using a self testing kit. They will explain what you need to do to take these samples. You also have a blood test.

Both groups have follow up visits. These are every:

4 months in group 1 for up to a year (4 visits in total)
6 months in group 2 for up to a year (3 visits in total)

At each visit the study team:

ask about your health
take blood samples
ask you to give vaginal samples using the self testing kit

Research samples

The researchers use the blood samples to:

look at your genetic material (DNA)
check how your immune system is working

They test the vaginal swabs for high risk HPV and find out more detailed information about any HPV strains.

They will keep any leftover samples for future research if you agree.

Hospital visits

You have 3 to 4 hospital visits if you join this study. The researchers will arrange the visits at a time that suits you. You receive £20 per visit to cover travel expenses and your time.

Side effects

Some women may feel embarrassed or uncomfortable talking about sexual contact. The study staff are trained to talk about this in a sensitive way and will only ask questions that are relevant to research.

Taking the vaginal swabs shouldn’t be too uncomfortable. The researchers explain how you do this.

Having a blood test is quick but it might leave a small bruise. Sometimes people feel a little light headed afterwards.