Raman spectroscopy in premalignant and malignant disease of the vulva

  • Research type

    Research Study

  • Full title

    Evaluation of the role of Raman spectroscopy in the diagnosis and management of premalignant and malignant disease of the vulva.

  • IRAS ID

    152140

  • Contact name

    Jonathan Frost

  • Contact email

    jonathan.a.frost@glos.nhs.uk

  • Sponsor organisation

    2gether NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    n/a, n/a

  • Research summary

    Can Raman spectroscopy be used to accurately diagnose and manage 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.

    Raman spectroscopy is a non invasive diagnostic tool that uses the scattering of light to identify the chemical make up of different tissues. The use of this tool may reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease. Ultimately many vulval skin conditions require treatment by surgical excision. Raman spectroscopy offers a potential tool to improve the chance of removing all the disease during surgery whilst minimising the extent of the surgery.

    The aim of this project is to validate the use of Raman spectroscopy in the diagnosis and management of vulval skin disease. This will be achieved by performing Raman spectroscopy on samples of tissue taken during the normal care of patients prior to performing routine tests. The results of the spectroscopy can then be compared with the routine tests and the accuracy of the new spectroscopic test determined.

    Patients attending Gloucestershire Hospitals NHS Foundation Trust for care of their vulval condition will be considered for inclusion within the study. Women will be asked for their consent prior to participation in the study and after an initial interview will not be asked to participate any further in the study. The study is funded by the Gloucestershire Hospitals NHS Foundation Trust Research and Innovation Forum.

  • REC name

    South West - Cornwall & Plymouth Research Ethics Committee

  • REC reference

    14/SW/1077

  • Date of REC Opinion

    23 Sep 2014

  • REC opinion

    Further Information Favourable Opinion