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

NCT02223975 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-08-04

No results posted yet for this study

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

Sponsors & Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-08-01
Completion
2018-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223975 on ClinicalTrials.gov