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

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ClinicalTrials.gov Identifier: NCT02735109
Recruitment Status : Unknown
Verified April 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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).


Condition or disease Intervention/treatment Phase
Vulvar Mucosa Lesions Vulvar Intraepithelial Neoplasia Other: photographies Procedure: biopsy normal area Not Applicable

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)....


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
Study Start Date : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
description
photographies and biopsy on normal area
Other: photographies
cells description by taken photographies vith confocal microscope (VivaScope 3000)

Procedure: biopsy normal area
biopsy done to compare with abnormal area




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method [ Time Frame: 12 months ]
  2. 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 [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02735109


Contacts
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Contact: Dorez maxence dorez.m@chu-nice.fr
Contact: Bonnard melanie bonnard.m@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06200
Contact: dorez maxence, PH       dorez.m@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02735109     History of Changes
Other Study ID Numbers: 14-AOI-13
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Keywords provided by Centre Hospitalier Universitaire de Nice:
VIN
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Vulvar Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female