Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease (Vulval VS)

Gloucestershire Hospitals NHS Foundation Trust

Status: Suspended

Conditions: Epithelial Hyperplasia Without Atypia; Pagets Disease of the Vulva; Squamous Cell Carcinoma; High Grade Dysplasia - Usual Type ('VIN 2-3'); Atypia Not Otherwise Specified/ Low Grade Dysplasia ('VIN 1'); Normal Vulval Skin; High Grade Dysplasia - Differentiated Type ('VIN 2-3'); Lichen Sclerosus

Study type: Observational

Funder types: Other

Identifiers

NCT02223975

14/040/GHT

Details and patient eligibility

About

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.

Full description

Design Ex vivo vibrational spectroscopic analysis of existing stored vulval and lymph node tissue samples collected from patients who have undergone treatment for vulval disease. Vibrational spectra are to be correlated with consensus histopathology and multivariate analysis to be used to evaluate the classification accuracy of vibrational spectroscopy ex vivo.

Aims

1. To establish vibrational spectral signal characteristics across a range of known vulval skin conditions.
2. To evaluate the ability of vibrational spectroscopic techniques to differentiate different vulval skin conditions.
3. To evaluate the ability of vibrational spectroscopy to detect diseased lymph nodes in women who have undergone surgery for vulval cancer.
4. To further the understanding of biochemical changes in a range of known vulval skin conditions.

Enrollment: 200 estimated patients

Sex: Female

Ages: 16 to 120 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Vulval Disease

Description:

Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.