Validation of HPV assays and collection devices
Research type
Research Study
Full title
EU-VALHUDES Study: European VALidation of Human papillomavirus assays and collection DEvices for HPV testing on Self vaginal and urine samples.
IRAS ID
275261
Contact name
Kate Cuschieri
Contact email
Sponsor organisation
Hiantis
Clinicaltrials.gov Identifier
Project GA-806551, European SME Instrument Project
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Human Papillomavirus is a common infection that usually clears by itself. However persistent infection with certain "high risk" HPV types can cause changes to cervical cells that can lead to cervical pre cancer and cancer. HPV testing is increasingly used for cervical disease management and screening in the UK using samples taken by a doctor or nurse. Recent evidence indicates that self taken samples may be used for HPV testing. This provides options for home testing in the future. The purpose of this study is to evaluate novel HPV tests and to determine if they work as well in self samples compared to a samples taken by a health care professional. This is a European study with sites based in Edinburgh, Ireland and Italy. The study will involve the recruitment of patients who are attending a routine colposcopy appointment (examination of the cervix) and we will ask the participants to provide a urine sample and a vaginal sample at the clinic. The health care professional would also take a "regular" sample for reasons of comparison. We will also ask participants to complete a brief questionnaire
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0221
Date of REC Opinion
30 Apr 2020
REC opinion
Favourable Opinion