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Clinical Trials/NCT02735109
NCT02735109
Terminated
Not Applicable

Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors

Centre Hospitalier Universitaire de Nice1 site in 1 country10 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vulvar Mucosa Lesions
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
10
Locations
1
Primary Endpoint
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

The confocal microscope is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as "optical" cuts in three dimensions in the thickness of the skin.

This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology.

The aim of the study is to describe the characteristics reproducibly for confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.

The patients seen in consultation with vulvar lesions suspicious looking will be included.

The results will be compared systematically to the histological results of biopsies of lesions (gold standard).

Detailed Description

The squamous cell carcinoma is the most common cancer of the vulva (90-95%), with a prognosis depending on the stage. The management of vulvar intraepithelial neoplasia (VIN) is a secondary prevention of squamous cell carcinoma of the vulva. Conventional VIN strongly associated with infection with oncogenic HPV (human papillomavirus) , present a risk of malignant degeneration of the order of 9-15%. Whereas the differentiated VIN, rarer often seen in the context of lichen sclerosis have a high risk of malignant degeneration ranging from 40 to 50%. The diagnosis is histological, biopsy realization is currently the gold standard before starting a cure. However, biopsies on the vulva are not a harmless act for patients, and are often repeated due to extensive damage. The early management of lesions VIN avoids changes in squamous cell carcinoma. Over their diagnosed early, the better the care and specific treatments allocated. The confocal microscope is a new imaging technology, already widely used for examination of the skin and mucous membranes. This is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as "optical" cuts in three dimensions in the thickness of the skin. The device will be used for this study is the VivaScope 3000. The advantage of the confocal microscope to discriminate between benign and malignant lesions of the skin and the oral mucosa has been shown in several prospective studies. Two recent studies have highlighted the promising results of the use of the confocal microscope for pigmented vulvar lesions (melanosis / melanoma). There is currently no data in the literature on the impact of this technique on the VIN and vulvar epidermoid carcinomas. This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology, to prove the contribution of the confocal microscope in vulvar intraepithelial neoplasia (VIN) and vulvar epidermoid carcinomas. The aim of the study is to describe the characteristics reproducibly confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma. The patients seen in consultation in the obstetrics and gynecology department and / or dermatology with a bow or vulvar lesions suspicious looking will be included in the study after signing an informed consent. The results will be compared systematically to the histological results of biopsies of lesions (gold standard). The investigators expect for this study a validation of the confocal microscope as a noninvasive diagnostic tool suspicious vulvar lesions (reduction of repeated biopsies, targeted biopsies to monitor certain lesions, and this even reduce health costs inherent to unnecessary biopsies)....

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age = 18 years, Female
  • Patient seen in consultation in the service of gynecology obstetrics, and, of dermatology of the Bow presenting during the medical examination one or several suspicious-looking vulvar hurts, suggestive of hurts of VIN or of carcinoma epidermoid vulvar
  • Membership health secure
  • Informed consent and paper of the obtained patient

Exclusion Criteria

  • Patient having already received a local treatment(processing) for hurts of VIN
  • Pregnant Woman
  • Patient under guardianship
  • Not signature of the written consent and/or mental deficiency of the subject making its participation on approval impossible

Outcomes

Primary Outcomes

Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope

Time Frame: 12 months

Secondary Outcomes

  • Caracteristics of thorny layer, of granular layer,of basal layer of vulvar mucosa lesions VIN to descriptions and the observations of with the normal mucosa(12 months)
  • Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method(12 months)

Study Sites (1)

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