Clinical trial · Observational
Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study suspended pending further funding
Summary
Brief summary (as posted)
Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin disorders are common and the diagnosis of these conditions can be difficult. Reliable discrimination between benign vulval skin conditions, precancerous conditions or vulval cancer often requires tissue biopsies. In addition the monitoring of patients with vulval disease at risk cancerous change is currently limited to visual assessment often supplemented by multiple invasive tissue biopsies. There are currently no established non invasive tests available for the diagnosis of vulval skin diseases. The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared spectroscopy are non invasive diagnostic tools that use the interaction of light within tissues to identify the chemical composition of different tissues. The use of these tools may reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease. The aim of this project is to explore the use of vibrational spectroscopic techniques in the diagnosis of vulval skin disease. This will be achieved by performing vibrational spectroscopy on samples of tissue previously taken from women with vulval skin disease treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy will be compared with the routine tests and the accuracy of spectroscopy determined.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypia Not Otherwise Specified/ Low Grade Dysplasia ('VIN 1') | Low Grade Vulvar Squamous Intraepithelial Lesion | ALIAS | 0.85 |
| Epithelial Hyperplasia Without Atypia | — | UNRESOLVED | — |
| High Grade Dysplasia - Differentiated Type ('VIN 2-3') | — | UNRESOLVED | — |
| High Grade Dysplasia - Usual Type ('VIN 2-3') | — | UNRESOLVED | — |
| Lichen Sclerosus | — | UNRESOLVED | — |
| Normal Vulval Skin | — | UNRESOLVED | — |
| Pagets Disease of the Vulva | Vulvar Paget Disease | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Vulval Disease
- description
- Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.
Primary outcomes (2)
- measure
- Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types
- timeFrame
- 2 years
- description
- * Normal vulval skin * Lichen Sclerosus * High grade dysplasia - Usual type ('Vulval Intraepithelial Neoplasia 2-3') * High grade dysplasia - Differentiated type ('Vulval Intraepithelial Neoplasia 2-3') * Squamous cell carcinoma
- measure
- Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
- timeFrame
- 2 years
- description
- Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Vulval skin tissue stored after routine histopathological analysis from women treated or investigated for a vulval skin condition. * Inguinofemoral lymph nodes stored after routine histopathological analysis from women treated for vulval cancer. Exclusion Criteria: * Tissue specimens inadequate for analysis.
References
Publications (0)
Data not yet available