ISGyP Risk Prediction in EAC Study
Research type
Research Study
Full title
Risk Prediction in Endocervical Adenocarcinoma: International Society of Gynecological Pathologists (ISGyP) Multi-Centre Retrospective Observational Study
IRAS ID
273971
Contact name
Naveena Singh
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Cervical cancer, a major cause of death in women worldwide, is usually caused by Human Papillomavirus (HPV) and can be of many different types. One type, known as endocervical adenocarcinoma (EAC) can also arise independently of HPV infection. In recent years it has become apparent that EAC that are HPV-associated (HPVA) have much better clinical outcomes than those that are not (NHPVA), that these can be distinguished through microscopic examination by pathologists, i.e. without expensive tests to detect HPV, and also that some HPVA cases are so indolent so that they can be treated with much less extensive surgery with no need for radiation or chemotherapy. At present all EAC are treated exactly the same way and, if validated this new knowledge can affect the treatment of thousands of women worldwide, avoiding both over- and under-treatment.
So far the studies on this issue have mostly been conducted by the expert pathologists who have developed the classification systems. In this study we would like to see if these classification systems are robust enough (i) to be used by all pathologists and (ii) to be incorporated into algorithms that can be used to plan treatment. We will ask pathologists from all over the world to learn the new classification systems, review the slides of EAC cases from their own hospitals, classify them using the new criteria, and send us their results, together with the clinical outcomes of the patients.
Members of two gynaecological pathology societies will be invited to provide completely anonymised data on adult women with EAC diagnosed and treated at their hospital. The data being collected are: patient age, date of diagnosis, pathology details from the original report and through slide review, treatment and follow-up data from the patient records. The analysis will be completed within 24 months of commencement.
REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0008
Date of REC Opinion
26 Feb 2020
REC opinion
Favourable Opinion