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

NCT02223975 | Suspended

• 1 other identifier: 14/040/GHT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types

  2 years

Study Arms (1)

Vulval Disease

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

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Tissue specimens inadequate for analysis.

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Histological sections of vulval and lymph node tissue.

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus; Carcinoma, Squamous Cell; Disease; Neoplasms; Vulvar Neoplasms; Vulvar Diseases

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

GB (1)