Predictors 5.1
Research type
Research Study
Full title
A randomised-assignment comparison study of the performance of self-collected vaginal samples for Human Papillomavirus (HPV) testing when transported under wet or dry conditions, using different collecting devices
IRAS ID
188448
Contact name
Louise Cadman
Contact email
Sponsor organisation
Barts Health NHS Trust
ISRCTN Number
ISRCTN68980717
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
•\tWho are we asking to participate?\n600 women referred after an abnormal smear test to the Colposcopy Clinic at the Royal London Hospital will be recruited to take part in the study. \n\n•\tWhy are we doing this study?\nWomen who test positive for high-risk HPV may be at risk of developing cervical cancer. High-risk HPV is associated with cervical cancer but most women clear the infection themselves and not develop cancer. We can test for HPV and in the future HPV testing is likely to replace cytology as the primary cervical screening test. It has the potential for self-sampling as a woman can use a simple swab or a commercially-designed swab kit to take a ’self-sample’ for HPV. This study aims to compare several of these methods. \n\n•\tWhat are we asking women to do?\nBefore their colposcopy examination women, who have signed a consent form to take part, will be asked to take two self-samples, either:\n1.\tSwabs (like cotton buds), one to be put in a tube with a small amount of liquid and the other into a dry tube.\nor\n2.\tQvintip and HerSwab self-test kits.\n300 women will, at random, be put into each group and given an illustrated instruction sheet. They will also be asked to fill in a short questionnaire about how easy or difficult they found taking each sample. Any smear and biopsy results from the colposcopy, and over the following 9 months or so, will be collected from hospital records.\nSelf-samples will be taken to the Centre for Cancer Prevention. HPV results will be not given to the woman or her doctor as we do not know how reliable they are for clinical care. \nTaking part in the study will not affect routine colposcopy care.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/2134
Date of REC Opinion
3 Feb 2016
REC opinion
Further Information Favourable Opinion