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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02735109
Enrollment
10
Registered
2016-04-12
Start date
2015-04-30
Completion date
2016-04-30
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar Intraepithelial Neoplasia, Vulvar Mucosa Lesions

Keywords

VIN

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)....

Interventions

OTHERphotographies

cells description by taken photographies vith confocal microscope (VivaScope 3000)

PROCEDUREbiopsy normal area

biopsy done to compare with abnormal area

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope12 months

Secondary

MeasureTime frame
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method12 months
Caracteristics of thorny layer, of granular layer,of basal layer of vulvar mucosa lesions VIN to descriptions and the observations of with the normal mucosa12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026