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

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.

Study Overview

• Status: Suspended
• Conditions: Lichen Sclerosus; Squamous Cell Carcinoma; Normal Vulval Skin; High Grade Dysplasia - Usual Type ('VIN 2-3'); High Grade Dysplasia - Differentiated Type ('VIN 2-3'); 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

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United Kingdom
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Gloucestershire Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 118 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Vulval Disease; Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types	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	2 years
Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.	Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Cancer; Diagnosis; Vulva; Multivariate analysis; Spectrum Analysis, vibrational; Spectrum Analysis, infrared; Spectrum Analysis, Raman; Spectrum Analysis; Fourier transform infrared spectroscopy; Raman probe; Optical; Vulval Intraepithelial Neoplasia; Vulvar Neoplasm; Vulvar Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Hyperplasia; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: 14/040/GHT