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

Cancer type:

Cervical cancer

Status:

Results

Phase:

Other

This study was for women who had a colposcopy because they had an abnormal cervical smear or HPV test. The women went to the Royal London Hospital colposcopy clinic.

This study was open for women to join between April 2016 and August 2017. These results were presented at a conference in 2019. 

More about this trial

The main way to diagnose abnormalities in your cervix is a cervical screening test. Left untreated, these abnormalities could lead to cancer. Testing for HPV Open a glossary item can also be done using the cervical screening sample. 

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

In this study researchers tested:

  • different ways of taking a sample from your vagina
  • using different swabs or brushes that you use yourself 

A urine sample was also taken. 

The researchers also looked at the best way to transport the vaginal samples to the lab. Some were transported in liquid and some were kept dry.

The researchers wanted to learn: 

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

They compared their findings with results from the samples taken during your colposcopy.

Summary of results

The study team found that 2 of the ways they tested and the urine sample were good methods for women to take their own samples. 

About this study
600 women joined this study. Everyone used 2 different methods to collect a sample from their vagina. Everyone also gave a urine sample. 

It was a randomised Open a glossary item study. Everyone was put into 1 of 4 groups. Which group they were in depended on the order they took the samples. 

There were 150 women in each group. They took the urine sample first followed by 2 different methods of taking the sample. 

In group 1, they used the dry Copan Floqswab then the Wet Digene Dracon swab. 

In group 2, they used the Wet Digene Dracon swab then the Copan Floqswab.

In group 3, they used the dry HerSwab then the dry Qvintip.

In group 4, they used the dry Qvintip then the dry HerSwab. 


Results
The team looked at the difference in the results of the first and second swab the women used. They found there was no difference between them. 

The researchers then combined the results of each swab from all groups. They looked at the number of times the result showed there was HPV present and how much was present. 

They found that the results of the  Copan Floqswab (DF), Wet Digene Dracon (WD) and the urine sample were similar.

For the Qvintip (QT) and HerSwab (HS) the number of results that showed how much HPV is present was lower. 


The team also looked at how abnormal the cells were (grade Open a glossary item) and how the swabs compared. They found that for the grade CIN Open a glossary item 2 and CIN3 the results from the swabs were similar. 

They then looked at the pairing of the swabs the women used in each group. And compared the results. They found that the Copan Floqswab and Wet Digene Dracon showed similar amounts of HPV. But agreement between the other pairings was lower. 

Conclusion
The team concluded the Copan Floqswab and Wet Digene Dracon swabs showed similar results. And were better than Qvintip, HerSwab and urine samples at detecting HPV.   

The Copan Floqswab, Wet Digene Dracon and urine samples are good methods for women to do self sampling for HPV. 

Although this study shows it is possible to use urine samples to screen for HPV it is not at the moment the preferred method. Using a urine sample to screen for HPV is still been evaluated. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Tony Hollingworth

Supported by

Barts Health NHS Trust
Cancer Research UK
Queen Mary University of London

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14594

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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