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

Sponsor

Gloucestershire Hospitals NHS Foundation Trust (Other)

Overall Status

Suspended

CT.gov ID

NCT02223975

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

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

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Vulval Disease Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.