Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease

Suspended

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

• Registration Number: NCT02223975
• Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04
• Primary Completion: 2018-08-01
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types	2 years	* 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
Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.	2 years	Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types	2 years	* Epithelial hyperplasia without atypia; * Atypia not otherwise specified/ Low grade dysplasia ('VIN 1'); * Pagets disease of the vulva

Trial Locations

Locations (1)

Gloucestershire Hospitals NHS Foundation Trust; 🇬🇧 Gloucester, Gloucestershire, United Kingdom