Clinical Trial: Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease

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 Summary:

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.

Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Current Primary Outcome:

• Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types [ Time Frame: 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. [ Time Frame: 2 years ]
  Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.

Original Primary Outcome: Same as current

Current Secondary Outcome: Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Gloucestershire Hospitals NHS Foundation Trust

Dates:
Date Received: August 21, 2014
Date Started: August 2014
Date Completion: August 2016
Last Updated: February 10, 2016
Last Verified: February 2016