ECCE: Enhanced Computerised Colposcopic Examination
Research type
Research Study
Full title
ECCE: Enhanced Computerised Colposcopic Examination
IRAS ID
266187
Contact name
Kina Bennett
Contact email
Sponsor organisation
Lancashire Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Title: ECCE: Enhanced Computerised Colposcopic Examination.
Objective: This study will explore the concept and feasibility of using ECCE during colposcopy examination.Relevance: Cervical cancer has a global incidence of 500 000 cases and a UK incidence of 3000 cases per annum. In the UK the number of cases is estimated to be 10 000 without a screening programme in place. Organised screening progammes detect precursors to cervical cancer and are highly effective at detecting disease (sensitivity of 80-85%). Colposcopy is the gold standard investigation and management tool for screen-positive women. However, colposcopy depends on the knowledge of the referral smear and the skill of the operator and this makes its diagnostic performance too poor to be used as a primary screening method in low income countries. Improving the accuracy of screening tests and providing immediate availability of results will further improve UK screening programmes and is a practical solution for use in low and middle income countries (LMICS). ECCE utilises a high performance camera embedded in a tablet shaped computer that will potentially be able to discriminate between normal and precancerous appearances of the cervix with superior diagnostic performance to colposcopy.
Design: A non-funded feasibility study using ECCE in 3 UK based NHS hospitals over 6 month period involving 1000 women.
Population: None pregnant or breastfeeding women who have been referred for colposcopy examination.
Intervention: This study involves taking an anonymised digital image of the cervix using the ECCE camera at the time of colposcopy. This non-invasive procedure will take between two and five minutes. The patient's referral smear, colposcopy appearance and biopsy results will also be recorded anonymously. This will be used to 'train' the artificial intelligence of the ECCE unit to improve its diagnostic performance. Clinicians will also complete a questionnaire to assess the usability of the device.
REC name
London - Stanmore Research Ethics Committee
REC reference
20/LO/0302
Date of REC Opinion
20 Mar 2020
REC opinion
Further Information Favourable Opinion