Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
Primary Purpose
Vulvar Mucosa Lesions, Vulvar Intraepithelial Neoplasia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
photographies
biopsy normal area
Sponsored by
About this trial
This is an interventional screening trial for Vulvar Mucosa Lesions focused on measuring VIN
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
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
description
Arm Description
photographies and biopsy on normal area
Outcomes
Primary Outcome Measures
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope
Secondary Outcome Measures
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method
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
Full Information
NCT ID
NCT02735109
First Posted
March 17, 2015
Last Updated
April 6, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02735109
Brief Title
Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
Official Title
Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)....
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Mucosa Lesions, Vulvar Intraepithelial Neoplasia
Keywords
VIN
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
description
Arm Type
Other
Arm Description
photographies and biopsy on normal area
Intervention Type
Other
Intervention Name(s)
photographies
Intervention Description
cells description by taken photographies vith confocal microscope (VivaScope 3000)
Intervention Type
Procedure
Intervention Name(s)
biopsy normal area
Intervention Description
biopsy done to compare with abnormal area
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorez maxence
Email
dorez.m@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnard melanie
Email
bonnard.m@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dorez maxence, PH
Email
dorez.m@chu-nice.fr
12. IPD Sharing Statement
Learn more about this trial
Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
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