Development of a prototype device for cervical cancer screening
Research type
Research Study
Full title
Development of a prototype device for cervical cancer screening
IRAS ID
235626
Contact name
Sanjeev Krishna
Contact email
Sponsor organisation
St George's University of London
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Cervical cancer is still a leading cause of death among women of reproductive age in most low resource countries. There are more than a half million cases of invasive cervical cancer (ICC) globally every year, and almost 300,000 women die as a consequence. Cervical cancer is caused by chronic and persistent infection with one or more oncogenic types of Human Papillomavirus (HPV). The majority, if not all, sexually active women will be infected with HPV during their lifetime, but most infections resolve without intervention. However, ~10% of women are unable to clear the infection, which can then progress to pre-cancer and cancer. Recently, several international organizations, including the WHO, have released new guidelines and recommendations favoring the use of HPV DNA testing for primary screening for cervical cancer instead of Papanicolaou (Pap) testing or visual inspection with acetic acid (VIA). In low and middle income countries (LIMCs), a suitable HPV DNA test would require minimal resources, would need to be mostly automated (limiting intervention by onsite staff), and would provide results in less than one hour. Such a test will allow country programs to implement same-day strategies in which women are screened, evaluated, and treated in one visit. \n\nThe aim of this project is to optimise and provide an initial evaluation of a preproduction prototype, point-of-care, cartridge-based, molecular HPV screening device with the use of clinical samples. Firstly, the prototype device will be optimised by testing clinical samples of known infection status in the laboratory (this will allow device cut-offs to be set). Secondly, the prototype device will be tested on blinded, freshly collected clinical samples to provide an initial assessment of the devices performance (e.g. determining sensitivity and specificity). This information will be used to the develop the device towards its final version, prior to full efficacy trials.\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0244
Date of REC Opinion
22 Nov 2018
REC opinion
Further Information Favourable Opinion