Developing a checklist to allow accurate diagnosis of vulval lichen sclerosus
| ISRCTN | ISRCTN76946205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76946205 |
| IRAS number | 332947 |
| Secondary identifying numbers | CPMS 59725, NIHR301434, IRAS 332947 |
- Submission date
- 25/04/2024
- Registration date
- 17/06/2024
- Last edited
- 26/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Vulval lichen sclerosus (LS) is an inflammatory vulval skin condition that typically presents as skin itching, thinning, splitting and whitening. If left untreated, this can progress to irreversible sticking together (scarring) of the skin. Discomfort caused by LS can therefore impact daily living, making activities such as sitting, walking, going to the toilet and sexual intercourse difficult. There is currently no specific checklist that can guide the diagnosis of vulval lichen sclerosus, 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.
Who can participate?
Women (over 18 years of age) who have been referred to a skin specialist with a vulval skin complaint by their GP
What does the study involve?
Participants 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.
What are the possible benefits and risks of participating?
The research team cannot promise that the study will help participants, but the information gained from this study may help better diagnose other people with a vulval complaint. If the checklist can be successfully introduced into primary care, it could be used as a tool to pick up cases earlier, enabling quicker access to treatment. It is not anticipated that there will be any risks associated with participating in this study.
Where is the study run from?
University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
April 2023 to February 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Rosalind Simpson, Rosalind.simpson@nottingham.ac.uk
Contact information
Scientific
University of Nottingham, University Park
Nottingham
NG7 2RD
United Kingdom
 ORCID ID |
0000-0002-6663-6541 |
|---|---|
| Phone | None provided |
| Rosalind.simpson@nottingham.ac.uk |
Public
University of Nottingham, University Park
Nottingham
NG7 2RD
United Kingdom
| ORCID ID |
0009-0000-7110-6150 |
|---|---|
| Phone | None provided |
| shells@nottingham.ac.uk |
Study information
| Study design | Observational cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Establishing effective diagnostic criteria for vulval lichen sclerosus: a diagnostic test accuracy study |
| Study acronym | SHELLS |
| Study objectives | A validated checklist of signs and symptoms (diagnostic criteria) will help to improve the accurate diagnosis of vulval lichen sclerosus in primary care and the community. |
| Ethics approval(s) |
Approved 21/05/2024, London - Camberwell St Giles Research Ethics Committee (Georgian House, 64-68 Camberwell Church St, London, SE5 8JB, United Kingdom; +44 (0)2071048222; camberwellstgiles.rec@hra.nhs.uk), ref: 24/LO/0290 |
| Health condition(s) or problem(s) studied | Vulval lichen sclerosus |
| Intervention | 407 consecutive women (≥18 years of age) who have been referred to a skin specialist by their GP with a vulval skin complaint will be identified by the usual care team from clinic lists. Patients will then be sent the patient information sheet and expression of interest form ahead of their appointment at the specialist clinic. Patients will have the opportunity to discuss all aspects of the study and provide consent either at the appointment or in advance. Once the participant has consented, the research team will ask some demographic and clinical questions, and then both the patient’s managing clinician and a second health professional who is blinded to the clinician's diagnosis will conduct separate vulval examinations. At one site (Nottingham), participants may be examined by a third blinded health professional. Optional clinical photographs will also be taken of the patient's LS condition. This will all occur in a single study visit that will last approximately 30 minutes. This information will be uploaded by the research site to the online database (REDCap) and the results will be analysed to assess the diagnostic accuracy of the criteria (from a previous electronic-Delphi consensus study registered at: https://www.nottingham.ac.uk/research/groups/cebd/documents/ls-protocol.pdf). The 17 expert-agreed diagnostic criteria are: • Changes in the anatomy of the genital area • Response to topical corticosteroids • Whiteness • Itch • Burying of the clitoral area • Absence of vaginal involvement • Fissuring • Crinkly skin • Bruising/bleeding under the skin • Fissuring at the back entrance to the vagina • Pain/soreness unrelated to sexual activity • Pain/soreness related to sexual activity • Skin thickening • Loss of skin stretchiness • Erosions • Irritation • Perianal fissure |
| Intervention type | Other |
| Primary outcome measure | To test a list of 17 expert-agreed diagnostic criteria measured using vulval clinical examination at one timepoint during a clinical consultation, to establish the best predictors for vulval lichen sclerosus and subsequently develop a diagnostic tool |
| Secondary outcome measures | Development of training resources/manual using qualitative methods, including input from patients and health professionals, to support the use of a future diagnostic tool at the end of the data collection |
| Overall study start date | 14/04/2023 |
| Completion date | 01/02/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 407; UK Sample Size: 407 |
| Key inclusion criteria | 1. Female 2. >=18 years of age 3. New presentation to a specialist clinic (secondary care or community hub) with a vulval skin complaint |
| Key exclusion criteria | 1. Inability to provide informed consent 2. Patients with surgical alteration of vulval skin as part of gender reaffirming surgery, or patients not born with a vulva 3. More than 2 weeks since initial consultation from managing clinician |
| Date of first enrolment | 27/09/2024 |
| Date of final enrolment | 01/08/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Oxford Road
Manchester
M13 9WL
United Kingdom
Salford
M6 8HD
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Newton Road
Torquay
TQ2 7AA
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Southampton
SO16 6YD
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Dundee
DD1 9SY
United Kingdom
Bridgend
CF31 1RQ
United Kingdom
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
United Kingdom
Luton
LU4 0DZ
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journals of relevant medical specialities (e.g. in dermatology, gynaecology and general medicine) |
| IPD sharing plan | The datasets analysed during the current study will be available upon request from the University of Nottingham (SHELLS@nottingham.ac.uk), a minimum of 6 months after publication of the main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the CI and sponsor and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be anonymised which may impact on the reproducibility of published analyses. Participants will provide consent for information obtained from their participation in the study to be anonymously shared. |
Editorial Notes
26/06/2025: The study participating centres were updated to remove Portsmouth Dermatology, King’s College, and Harrogate and add Bedfordshire Hospitals NHS Foundation Trust and Royal Victoria Infirmary (Newcastle Upon Tyne Hospitals Foundation Trust).
02/10/2024: The recruitment start date was changed from 01/10/2024 to 27/09/2024. Ninewells Hospital, Princess of Wales Hospital, Harrogate & District NHS Foundation Trust and Pinderfields Hospitals NHS Trust were added as study participating centres.
25/09/2024: The recruitment start date was changed from 01/09/2024 to 01/10/2024.
06/08/2024: The recruitment start date was changed from 01/08/2024 to 01/09/2024.
09/07/2024: The following changes were made to the study record:
1. Ethics approval details added.
2. The overall study end date was changed from 15/12/2026 to 01/02/2027.
3. County Durham and Darlington NHS Foundation Trust and Royal Devon University Healthcare NHS Foundation Trust were added to the study participating centres.
02/07/2024: Internal review.
01/07/2024: Internal review.
25/04/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
