Establishing Effective Diagnostic Criteria for Lichen Sclerosus V1.0
Research type
Research Study
Full title
Establishing Effective Diagnostic Criteria for Vulval Lichen Sclerosus: A Diagnostic Test Accuracy Study
IRAS ID
332947
Contact name
Rosalind Simpson
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
There is currently no specific checklist that can guide the diagnosis of vulval lichen sclerosus (LS), and as such, the condition is often misdiagnosed, or that diagnosis is delayed. This study aims to improve the diagnosis of LS through testing an internationally expert-agreed 'checklist' (diagnostic criteria) in a clinical setting to help non-experts and patients identify LS more easily. 407 women (≥18 years of age) who have been referred to a skin specialist with a vulval skin complaint by their GP will attend a single research appointment where both the patient’s managing clinician and a second health professional who is blinded to the clinician's diagnosis will conduct separate vulval examinations, in addition to taking optional clinical photographs of the patient's LS condition. This will enable the assessment of how well the checklist can identify LS compared to other vulval complaints.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
24/LO/0290
Date of REC Opinion
21 May 2024
REC opinion
Further Information Favourable Opinion