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

Squamous Cell Carcinoma Clinical Trial

— Vulval VS  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02223975
• Other study ID #: 14/040/GHT
• Status: Suspended
• Phase: N/A
• First received: August 21, 2014
• Last updated: August 3, 2017
• Start date: August 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2017
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Gloucester	Gloucestershire

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   Biophotonics Research Unit