PREDICTORS 5.0 - Stability Study
Research type
Research Study
Full title
A study comparing the stability for human papillomavirus testing of three dry vaginal self-samples taken by women attending a colposcopy clinic
IRAS ID
178300
Contact name
Louise Cadman
Contact email
Sponsor organisation
Queen Mary, University of London, Joint Research Office
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
60 women from the Colposcopy Clinic at the Royal London Hospital will be recruited, having been referred following an abnormal cervical screening result.
Aim
Human Papillomavirus (HPV) is very common and can cause cervical cancer in some women. There is interest in HPV testing in place of the smear test currently used for cervical screening. HPV testing has potential for women to take self-samples.
These self-samples have up to now mostly been placed into liquid to preserve them before testing. Using liquid however, makes it more difficult to collect samples at home due to spillage and the logistics of posting. We plan to investigate whether dry samples are reliable. We would also like to know if samples can still be used if not tested immediately, particularly in warm temperatures. This would prove useful in the countries that have found it difficult to set up national cervical screening programmes.
Trial Design
We are asking women to take three vaginal self-samples before their
colposcopy examination. The samples will be two swabs and a third using the HerSwab device, designed to make taking a sample easier. We will give women instruction sheets with illustrations. Their samples, taken in a random order so that all samples have an equal chance, will be sent to the laboratory for testing but under different conditions. They will be either frozen immediately, stored at 25ºC for one week or two weeks and then frozen. All samples will then undergo HPV testing. We wish to see if all conditions and swabs provide similar amounts of HPV.
Enrolment is planned to start in May 2015. Sample processing and testing will continue until enrolment is complete and for a further month. Smear and biopsy results will be collected for up to 6 months to see if they affect quantities of HPV.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/0950
Date of REC Opinion
5 Jun 2015
REC opinion
Favourable Opinion