CINtec PLUS triage in HPV primary screening
Research type
Research Study
Full title
CINtec PLUS triage of HPV positive women in HPV primary screening
IRAS ID
256073
Contact name
Mary McMenamin
Contact email
Sponsor organisation
Research & Development Office
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The current cervical screening method is cytology with HPV triage to colposcopy. The UK National Screening Committee has recommended that HPV testing should be the primary test with cytology triage. This is currently being rolled out in parts of the UK. However, there are concerns that cytology triage is not sufficient to safeguard women from possible over referral. Also, expediting referral of women who are at high risk of disease to colposcopy is possible with new triage tests. This study will evaluate the clinical performance of the CINtec PLUS test as a further triage test in a HPV primary screening population. The study will recruit women (9800) prospectively by verbal invitation from the sample taker when women attend for their cervical cytology screening test. Women in the study will undergo primary HPV testing in addition to their normal cervical cytology screening test. No additional samples will need to be collected as study testing will be conducted on residual samples. The main deviation from the normal patient pathway is that a small proportion of the study population (approx. 1.6%) who test positive with the tests that are being evaluated in the study, will be referred to colposcopy for investigation. The study will provide an estimate of the percentage of cases wherein a delayed diagnosis of prevalent CIN2+ is preventable by triaging HPV positive women with CINtec PLUS.
The study will also provide a measure of the percentage of unnecessary colposcopies that can be avoided when employing CINtec PLUS for triaging women who primary screen HPV positive.
Clinical outcomes will be recorded and the risk of disease will be evaluated for all women in the study. Subsequently, clinical performance of CINtec PLUS will be evaluated.REC name
West of Scotland REC 3
REC reference
19/WS/0038
Date of REC Opinion
6 Jun 2019
REC opinion
Further Information Favourable Opinion