Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02735109 |
| Other study ID # |
14-AOI-13 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2015 |
| Est. completion date |
April 2016 |
Study information
| Verified date |
January 2024 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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)....
