A study comparing a urine sample and different ways of collecting and transporting vaginal samples for HPV testing

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

Cancer type:

Cervical cancer

Status:

Closed

Phase:

Other

This study is for women who are due to have a colposcopy because they have had an abnormal cervical smear or HPV test. The women need to be attending the Royal London Hospital colposcopy clinic.

More about this trial

Having a cervical screening test is the main way you can be diagnosed with abnormalities in your cervix that, if left untreated, could lead to cancer. The sample taken during your cervical screening might also be tested for HPV Open a glossary item .

But there are newer ways of taking samples that women might prefer.

In this study researchers want to test different ways of taking a sample of the inside of your vagina using different swabs or brushes that you use yourself. They will also ask for a urine sample.

After you have done your samples the researchers will transport the vaginal samples to the lab in different ways. Some will be in liquid and some will be kept dry.

The researchers want to learn

the best way of collecting vaginal samples and transporting them
how the results of different tests on these samples and urine compare

They will also compare their findings with results from any samples you have taken during your colposcopy.

Neither you nor your doctor will be told the results of the swabs and urine sample as they are for research purposes only. Taking part in this study will not change any treatment you might need.

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.

You may be able to join this study if you are attending the Royal London Hospital colposcopy clinic for an examination and all of the following apply. You

Have had an abnormal cervical screening test result
Are aged 18 or older

You cannot join this study if any of these apply. You

Have had your cervix removed
Have had any treatment for cervical intraepithelial neoplasia (CIN) in the last 3 years
Are pregnant

Trial design

Researchers hope that 600 women will take part in this study.

At the colposcopy clinic a member of the research team will explain the study to you and give you an opportunity to ask questions. If you decide to take part you’ll sign a consent form Open a glossary item .

After you sign the form you:

give a urine sample using a special device designed just to collect the first bit of urine you pass
take two vaginal samples using either swabs (like a cotton bud but with a longer handle) or special devices with a brush – the researchers will give you written instructions and diagrams on how to do this
complete a simple questionnaire on your experience of giving the samples

You then continue with your colposcopy appointment as usual.

About 6 months after your appointment the researchers will look at your medical records so they can collect the results of any tests done during your colposcopy.