URINE HPV TESTING AS AN ALTERNATIVE METHOD TO CYTOLOGY
Research type
Research Study
Full title
A Comparitive Study: Urine HPV detection as alternative and non-invasive method to diagnostic cytology.
IRAS ID
179178
Contact name
David Bailey
Contact email
Sponsor organisation
Middlesex University
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
AIM:
To compare the sensitivity and specificity of urine HPV testing as an alternative and non-invasive method for detecting high grade Cervical Intraepithelial Neoplasia.
Data of urine HPV genotyping will be compared to the standard cellular sampling of the cervix and histology outcomes.
Details of Recruitment:
Urine HR HPV testing will be carried out on approximately 50 women who have been referred to Colposcopy Clinic as a result of a high grade cytology pap smear result. Eligible women will be offered information on the additional urine sample requested. Participant should be 24.5 years or older and have had no previous treatment for cervical disease, no previous chemotherapy or radiation for cervical disease, not pregnant, no known HIV infection/AIDS, no previous hysterectomy and be able to give informed consent.
Consent:
All women will be asked for consent at the Colposcopy Clinic prior to collecting their urine samples and the details of the study will be explained to them.
Methods:
Consenting participants will provide urine samples prior to colposcopy examination. Treatment of participants will be carried out according to the current NHSCSP Colposcopy and Programme Management guidelines.
• 50 urine samples will HPV tested.
• These will be compared with histology outcomes from the treatment carried out in the Colposcopy Clinic as well as the cytology HPV results.
• Urine samples will be collected using the Chlamydia buffer kits and the testing will be carried out using the same programme as the cytology HPV testing programme on the Roche Cobas machine.
The results of the urine HPV test will not affect the participants’ treatment as they will be under colposcopy management.REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0170
Date of REC Opinion
15 Jun 2015
REC opinion
Further Information Favourable Opinion