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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02223975
Other study ID # 14/040/GHT
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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