Over 1300 women in the UK are diagnosed with vulval cancer each year. The vulva are the external female genitals. Early diagnosis of vulval cancer is important as an early cancer can be cured with an operation. There is no screening programme for vulval cancer, but some women are at increased risk. These are women with chronic skin conditions including lichen sclerosus, lichen planus and vulval intraepithelial neoplasia. Often, these conditions are difficult to diagnose and can go unrecognised by both patients and doctors. Understanding who is at risk of developing vulval cancer is an important research question which was identified as a priority by clinicians, scientists and patients with lichen sclerosus.
The aims of the study are to establish the number of women and children diagnosed with lichen sclerosus, lichen planus and vulval intraepithelial neoplasia in the UK. We also want to quantify the risk of developing vulval cancer in these high risk women compared with those with no risk factors. Finally, we want to understand how long it takes for vulval cancer to develop in these women and how they are diagnosed (for e.g. through the GP or in hospital). Primary care data accessed through the Clinical Practice Research Datalink and national cancer data will be linked to help us address these aims. We hope to use these findings to quantify the risk of vulval cancer in high risk populations and develop risk prediction strategies to tailor treatment and follow-up for the early detection of vulval cancer.
Vulval squamous cell carcinoma (VSCC) is diagnosed in 1300 British women annually. Early detection of vulval cancer reduces surgical morbidity and improves survival. While there is no role for population-based screening, some skin conditions increase the risk of vulval cancer, including lichen sclerosus (LS), lichen planus (LP)] and intraepithelial neoplasia (VIN). A priority research question is “What is the risk of developing cancer in vulval lichen sclerosus?". A cancer risk prediction model aid in personalising risk, tailor follow-up to reduce intensity of clinician assessments and design population-based interventions.
The four aims of the study are:
1. to establish the incidence and prevalence of lichen sclerosus(LS), lichen planus(LP) and vulval intraepithelial neoplasia(VIN) in females using a UK population approach
2. to establish the incidence of VSCC in females with LS, LP and VIN and to compare the risk of VSCC in females at increased risk using a matched-cohort study approach.
3. to establish the interval between diagnosis of a precursor condition (LS, LP and VIN) to the development of VSCC
4. to establish the route of diagnosis of 1st presentation of VSCC and the impact of this on treatment and survival outcomes.
Data will be obtained from CPRD Gold and Aurum. Study populations are as follows:
Aim 1: Any female with a diagnosis of LS or LP between 01/01/1998-30/06/2020.
Aim 2 and 3: Any woman with a diagnosis of LS, LP, VIN and/or vulval cancer between 01/01/1998-31/12/2018 for NCRAS linkage.
Aim 4: Any woman with a diagnosis of LS, LP, VIN and/or vulval cancer between 01/01/2003-31/12/2018 for HES OP linkage.
Hazard ratios for outcomes of interest among women with LS/LP/VIN, as compared with female controls, will be estimated from Cox regression models. All analyses will be replicated in an age-matched cohort of women with no history of vulval skin conditions.
Outcome1 – Incidence and Prevalence of Lichen Sclerosus, Lichen Planus and Vulval Intraepithelial Neoplasia in England
Outcome 2 – Incidence of vulval squamous cell carcinoma in women with Lichen Sclerosus, Lichen Planus and Vulval Intraepithelial Neoplasia compared with general female population.
Outcome 3- Route of diagnosis of all vulval squamous cell carcinomas and the impact of this on treatment and survival outcomes.
Vanitha Sivalingam - Chief Investigator - University of Manchester
Vanitha Sivalingam - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Caroline Owen - Collaborator - Not from an Organisation
Darren Ashcroft - Collaborator - University of Manchester
Emma Crosbie - Collaborator - University of Manchester
Fiona Walter - Collaborator - University of Cambridge
Garth Funston - Collaborator - University of Cambridge
HES Admitted Patient Care;HES Outpatient;NCRAS Cancer Registration Data;No additional NCRAS data required;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation