Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease (Vulval VS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02223975
Recruitment Status : Suspended (Study suspended pending further funding)
First Posted : August 22, 2014
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Jonathan Frost, 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.


Condition or disease
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

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease
Study Start Date : August 2014
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Vulval Disease
Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.



Primary Outcome Measures :
  1. Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types [ Time Frame: 2 years ]
    • 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. Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma. [ Time Frame: 2 years ]
    Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.


Secondary Outcome Measures :
  1. Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types [ Time Frame: 2 years ]
    • Epithelial hyperplasia without atypia
    • Atypia not otherwise specified/ Low grade dysplasia ('VIN 1')
    • Pagets disease of the vulva


Biospecimen Retention:   Samples With DNA
Histological sections of vulval and lymph node tissue.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223975


Locations
Layout table for location information
United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust

Layout table for additonal information
Responsible Party: Dr Jonathan Frost, Clinical Research Fellow, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02223975     History of Changes
Other Study ID Numbers: 14/040/GHT
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Keywords provided by Dr Jonathan Frost, Gloucestershire Hospitals NHS Foundation Trust:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Lichen Sclerosus et Atrophicus
Hyperplasia
Pathologic Processes
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases