Clinical trial NCT02223975: Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease
Official title: Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: 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
Keywords: Spectrum Analysis, vibrational
Spectrum Analysis, infrared
Spectrum Analysis, Raman
Spectrum Analysis
Fourier transform infrared spectroscopy
Raman probe
Optical
Diagnosis
Cancer
Multivariate analysis
Vulval Intraepithelial Neoplasia
Vulvar Neoplasm
Vulva
Vulvar Diseases
Lead sponsor: Gloucestershire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types
timeFrame: 2 years
measure: Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types
timeFrame: 2 years
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
state: Gloucestershire
Study officials:
References: